| 1 |
NCT03598257 |
Recruiting |
Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer |
- Inflammatory Breast Carcinoma
|
- Drug: Olaparib
- Radiation: Radiation Therapy
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Invasive Disease-Free Survival (IDFS)
- Locoregional Recurrence-Free Interval (Local Disease-Free Interval (LDFI))
- Distant Relapse-Free Survival (Distant Recurrence-Free Survival)
- Overall Survival
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT03598257 |
NCI-2018-01519
S1706
U10CA180888 |
|
September 12, 2018 |
July 31, 2023 |
July 31, 2023 |
July 25, 2018 |
November 9, 2018 |
|
- Iowa Methodist Medical Center
Des Moines, Iowa, United States - Bozeman Deaconess Hospital
Bozeman, Montana, United States - Nebraska Methodist Hospital
Omaha, Nebraska, United States
|
|
| 2 |
NCT02876107 |
Recruiting |
A Phase II Study of Using Panitumumab/Carboplatin/Paclitaxel (PaCT) Followed by Anthracycline-Containing Regimen (AC) for New Triple-Negative Inflammatory Breast Cancer (TN-IBC) |
- Malignant Neoplasm of Breast
|
- Procedure: Breast Core Biopsy
- Drug: Paclitaxel
- Drug: Carboplatin
- (and 6 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Amgen
- M.D. Anderson Cancer Center
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete Pathologic Response (pCR) Rate
- Disease-Free Survival (DFS) Rate
|
72 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02876107 |
2016-0177
NCI-2017-00619 |
|
October 2016 |
October 2023 |
October 2024 |
August 23, 2016 |
July 26, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 3 |
NCT02971748 |
Recruiting |
A Study of Anti-PD-1 (Pembrolizumab) + Hormonal Therapy in HR-positive Localized IBC Patients With Non-pCR to Neoadjuvant Chemotherapy |
- Inflammatory Breast Cancer
- Malignant Neoplasm of Breast
|
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Merck Sharp & Dohme Corp.
- M.D. Anderson Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease-free survival (DFS)
|
37 |
All |
18 Years and older (Adult, Older Adult) |
NCT02971748 |
2016-0096
NCI-2018-01297 |
|
January 26, 2017 |
January 2020 |
January 2021 |
November 23, 2016 |
August 1, 2018 |
|
- The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 4 |
NCT03202316 |
Recruiting |
Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) in Patients With Recurrent/Metastatic Inflammatory Breast Cancer |
- Malignant Neoplasm of Breast
|
- Drug: Cobimetinib
- Drug: Atezolizumab
- Drug: Eribulin
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Genentech, Inc.
- M.D. Anderson Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of Cobimetinib Plus Atezolizumab and Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer
- Overall Response Rate (ORR) of Cobimetinib Plus Atezolizumab and Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer
- Clinical Benefit Rate (CBR) of Cobimetinib Plus Atezolizumab and Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer
- (and 3 more...)
|
33 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03202316 |
2016-0890
NCI-2017-01601 |
|
August 11, 2017 |
August 2020 |
August 2021 |
June 28, 2017 |
July 10, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 5 |
NCT02411656 |
Recruiting |
MK-3475 for Metastatic Inflammatory Breast Cancer (MIBC) |
|
- Drug: MK-3475
- Behavioral: Follow Up/Phone Call
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Merck Sharp & Dohme Corp.
- M.D. Anderson Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
35 |
All |
18 Years and older (Adult, Older Adult) |
NCT02411656 |
2014-0533
NCI-2015-00671 |
|
June 2015 |
June 2020 |
June 2020 |
April 8, 2015 |
November 14, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 6 |
NCT01325428 |
Completed
Has Results |
Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer |
|
- Drug: Afatinib once daily (OD)
- Drug: Vinorelbine Weekly
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
- Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
- Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
- (and 8 more...)
|
26 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01325428 |
1200.89
2010-024454-10 |
|
August 2011 |
November 2014 |
November 2014 |
March 29, 2011 |
July 19, 2016 |
February 11, 2016 |
- 1200.89.10001 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States - 1200.89.10005 Boehringer Ingelheim Investigational Site
Durham, North Carolina, United States - 1200.89.61002 Boehringer Ingelheim Investigational Site
East Bentleigh, Victoria, Australia - (and 13 more...)
|
|
| 7 |
NCT01262027 |
Active, not recruiting
Has Results |
TKI258 for Metastatic Inflammatory Breast Cancer Patients |
|
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Novartis
- M.D. Anderson Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants
- Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)
|
22 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01262027 |
2010-0296
NCI-2011-00299 |
|
January 27, 2012 |
November 2015 |
December 2017 |
December 17, 2010 |
June 15, 2017 |
February 2, 2017 |
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 8 |
NCT00558103 |
Completed
Has Results |
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer |
|
- Drug: lapatinib
- Drug: Pazopanib
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions
- Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression
- Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)
- Overall Survival
|
163 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00558103 |
VEG108838 |
|
December 2007 |
May 2011 |
December 2011 |
November 14, 2007 |
February 4, 2013 |
July 18, 2012 |
- GSK Investigational Site
Long Beach, California, United States - GSK Investigational Site
Sacramento, California, United States - GSK Investigational Site
Denver, Colorado, United States - (and 123 more...)
|
|
| 9 |
NCT02324088 |
Completed |
Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer |
- Inflammatory Breast Cancer
|
- Drug: Docetaxel
- Drug: Cyclophosphamide
- Drug: Epirubicin
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- disease-free survival rate
|
174 |
Female |
18 Years to 60 Years (Adult) |
NCT02324088 |
PEGASE 7/0002 |
PEGASE07 |
October 2000 |
December 2012 |
January 2015 |
December 24, 2014 |
May 8, 2017 |
|
|
|
| 10 |
NCT00756470 |
Terminated
Has Results |
Phase II Neoadjuvant in Inflammatory Breast Cancer |
|
- Drug: Lapatinib
- Drug: Paclitaxel
- Drug: 5-Fluorouracil (5-FU)
- (and 2 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- GlaxoSmithKline
- M.D. Anderson Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
- Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population)
|
15 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00756470 |
2007-0818 |
|
October 2008 |
October 2013 |
October 2013 |
September 22, 2008 |
November 17, 2014 |
November 5, 2014 |
- UT MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 11 |
NCT00118053 |
Terminated
Has Results |
Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer |
|
- Biological: herceptin
- Drug: carboplatin
- Drug: docetaxel
- (and 2 more...)
|
Interventional
|
Phase 2 |
- University of Medicine and Dentistry of New Jersey
- National Cancer Institute (NCI)
- Aventis Pharmaceuticals
- Rutgers, The State University of New Jersey
|
Other / NIH / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Antitumor Activity as Measured by Response Rate
- Pathological Complete Response
- Disease-free Survival
- Pathologic and Molecular Markers for Predicting Efficacy
|
5 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00118053 |
040412;CDR0000433511
P30CA072720
CINJ-040412
0220045191
CINJ-NJ1104 |
|
April 2005 |
December 2008 |
December 2008 |
July 11, 2005 |
November 20, 2013 |
November 20, 2013 |
- Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, United States - CentraState Medical Center
Freehold, New Jersey, United States - Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States - (and 6 more...)
|
|
| 12 |
NCT02389764 |
Terminated |
Nintedanib For HER2-Negative Metastatic Inflammatory Breast Cancer (MIBC) |
|
- Drug: BIBF 1120
- Behavioral: Phone Call
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Boehringer Ingelheim
- M.D. Anderson Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Benefit Rate (CBR) of BIBF-1120 in Metastatic Inflammatory Breast Cancer (IBC)
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT02389764 |
2014-0464
NCI-2015-00506 |
|
June 22, 2015 |
June 8, 2018 |
June 8, 2018 |
March 17, 2015 |
July 3, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 13 |
NCT03515798 |
Not yet recruiting |
Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer |
- Inflammatory Breast Cancer
|
- Drug: Pembrolizumab Injection
- Drug: neoadjuvant (F)EC-paclitaxel chemotherapy
|
Interventional
|
Phase 2 |
- Institut Paoli-Calmettes
- MSD France
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Central evaluation of pathological complete response rate
- Dose Limiting Toxicity (DLT) rates
- occurrence of serious adverse events and adverse events starting grade 2 or grade 1 (run-in period)
- (and 4 more...)
|
81 |
All |
18 Years and older (Adult, Older Adult) |
NCT03515798 |
PELICAN-IPC 2015-016
2016-001868-11 |
PELICAN |
June 30, 2018 |
December 30, 2020 |
April 30, 2025 |
May 4, 2018 |
May 4, 2018 |
|
- Institut Sainte Catherine
Avignon, France - Institut BERGONIE
Bordeaux, France - CENTRE Francois Baclesse
Caen, France - (and 11 more...)
|
|
| 14 |
NCT00793390 |
Completed |
Case-Control Study of Inflammatory Breast Cancer in North Africa |
|
|
Observational
|
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
|
773 |
Female |
18 Years to 100 Years (Adult, Older Adult) |
NCT00793390 |
999909033
09-C-N033 |
|
November 17, 2008 |
|
|
November 19, 2008 |
November 16, 2018 |
|
- National Cancer Institute-Cairo
Cairo, Egypt - Gharbia Cancer Society
Gharbia, Egypt - Tanta Cancer Center
Tanta, Egypt - (and 3 more...)
|
|
| 15 |
NCT02623972 |
Recruiting |
A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer |
- Inflammatory Breast Cancer
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
|
- Drug: Eribulin
- Drug: Adriamycin
- Drug: Cyclophosphamide
|
Interventional
|
Phase 2 |
- Dana-Farber Cancer Institute
- Eisai Inc.
- Dana-Farber Cancer Institute
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic Complete Response
- Disease Free Survival
- Time to Treatment Failure
- (and 4 more...)
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT02623972 |
15-292 |
|
December 2015 |
February 2019 |
February 2023 |
December 8, 2015 |
May 22, 2018 |
|
- Brigham and Women's Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
|
| 16 |
NCT02876302 |
Recruiting |
Study Of Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer |
- Inflammatory Breast Cancer (IBC)
|
- Drug: Ruxolitinib
- Drug: Paclitaxel
- Drug: Doxorubicin
- Drug: Cyclophosphamide
|
Interventional
|
Phase 2 |
- Dana-Farber Cancer Institute
- Incyte Corporation
- Dana-Farber Cancer Institute
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Assess JAK Inhibition With Ruxolitinib On pStat3+ Expression
- Determine Pathologic Complete Response rate (pCR) after preoperative therapy
- Correlate effects on pSTAT3+ and STAT3 gene expression with pCR
- (and 9 more...)
|
64 |
All |
18 Years and older (Adult, Older Adult) |
NCT02876302 |
16-151 |
|
April 26, 2017 |
February 2020 |
February 2024 |
August 23, 2016 |
September 10, 2018 |
|
- Johns Hopkins University
Baltimore, Maryland, United States - Johns Hopkins at Green Spring Station
Lutherville, Maryland, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - (and 5 more...)
|
|
| 17 |
NCT01938833 |
Terminated
Has Results |
Romidepsin and Abraxane in Treating Patients With Metastatic Inflammatory Breast Cancer |
- HER2-negative Breast Cancer
- Inflammatory Breast Cancer
- Male Breast Cancer
- (and 2 more...)
|
- Drug: Romidepsin
- Drug: Abraxane
|
Interventional
|
Phase 1
Phase 2 |
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- Celgene Corporation
- Thomas Jefferson University
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum-Tolerated Dose of Romidepsin (Phase I)
- Progression-Free Survival (PFS)
- Incidence of Adverse Events, Graded According to NCI CTCAE Version 4.0
- (and 2 more...)
|
9 |
All |
18 Years and older (Adult, Older Adult) |
NCT01938833 |
13C.387
2013-035 |
|
April 2014 |
August 18, 2016 |
December 8, 2016 |
September 10, 2013 |
December 28, 2017 |
September 29, 2017 |
- Thomas Jefferson University
Philadelphia, Pennsylvania, United States
|
|
| 18 |
NCT00646555 |
Completed |
Inflammatory Breast Cancer, Tumor Markers, and Factors Associated With Angiogenesis |
|
|
Observational
|
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT00646555 |
999904051
04-C-N051 |
|
November 20, 2003 |
|
April 10, 2012 |
March 28, 2008 |
July 2, 2017 |
|
- GW University Medical Center GW Hospital Center
Washington, D.C., District of Columbia, United States
|
|
| 19 |
NCT00005822 |
Completed |
SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer |
|
- Drug: doxorubicin hydrochloride
- Drug: semaxanib
- Procedure: conventional surgery
- (and 2 more...)
|
Interventional
|
Phase 1 |
- Case Comprehensive Cancer Center
- National Cancer Institute (NCI)
- Case Comprehensive Cancer Center
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the maximum tolerated dose of SU5416 and doxorubicin in patients with stage IIIB or IV inflammatory breast cancer.
|
21 |
All |
18 Years and older (Adult, Older Adult) |
NCT00005822 |
CWRU5199
U01CA062502
P30CA043703
CWRU-5199
NCI-T99-0099 |
|
April 2000 |
December 2002 |
October 2003 |
January 27, 2003 |
June 11, 2010 |
|
- Ireland Cancer Center at University Hospitals Case Medical Center
Cleveland, Ohio, United States
|
|
| 20 |
NCT01880385 |
Unknown † |
Efficacy and Safety of Bevacizumab in the Neodjuvant Treatment of Inflammatory Breast Cancer |
- Inflammatory Breast Cancer
|
- Biological: Bevacizumab
- Drug: Cyclophosphamide
- Drug: epirubicin hydrochloride
- (and 3 more...)
|
Interventional
|
Phase 1 |
- Association Tunisienne de lutte Contre le Cancer
- Hoffmann-La Roche
- Sanofi
- Association Tunisienne de lutte Contre le Cancer
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pathologic Complete Response (pCR)
- Toxicity as assessed by CTCAE v3.0
- Progression-free survival
- Overall survival
|
30 |
Female |
20 Years to 75 Years (Adult, Older Adult) |
NCT01880385 |
ML25168 |
Beva |
March 2011 |
September 2013 |
April 2017 |
June 19, 2013 |
June 19, 2013 |
|
- Institut Salah Azaiz
Bab Saadoun, Tunis, Tunisia
|
|
| 21 |
NCT00016549 |
Completed |
Bevacizumab to Treat Inflammatory Breast Cancer or Locally Advanced Breast Cancer |
|
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
- To determine in IBC or LABC whether a change in any of the 4 angiogenesis parameters; 3 primary molecular parameters or the dynamic MRI parameter can be detected from baseline to 3 wks after treatment with bevacizumab.
- To attempt to correlate each of the four primary parameters with clinical findings and time to progression/recurrence.
|
21 |
All |
18 Years and older (Adult, Older Adult) |
NCT00016549 |
010173
01-C-0173 |
|
May 13, 2001 |
January 29, 2007 |
January 29, 2007 |
May 17, 2001 |
July 2, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 22 |
NCT03101748 |
Recruiting |
A Phase 1b Study of Neratinib, Pertuzumab and Trastuzumab With Taxol (3HT) in Primary Metastatic and Locally Advanced Breast Cancer, and Phase II Study of 3HT Followed by AC in HER2 + Primary IBC, and Neratinib With Taxol (NT) Followed by AC in HR+ /HER2- Primary IBC |
- Malignant Neoplasm of Breast
|
- Drug: Neratinib
- Drug: Paclitaxel
- Drug: Pertuzumab
- (and 3 more...)
|
Interventional
|
Phase 1
Phase 2 |
- M.D. Anderson Cancer Center
- Puma Biotechnology, Inc.
- M.D. Anderson Cancer Center
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of Neratinib in Combination with Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive (HER2+) Primary Metastatic or Locally Advanced Breast Cancer
- Pathologic Complete Response (pCR) Rate of Neratinib in Combination with Paclitaxel, Pertuzumab, and Trastuzumab Followed by Doxorubicin and Cyclophosphamide (AC) in HER2+ Locally Advanced Inflammatory Breast Cancer (IBC) Patients
- Pathologic Complete Response (pCR) Rate of Neratinib in Combination with Paclitaxel Followed by Doxorubicin and Cyclophosphamide in HER2-Negative/ER-Positive (HER2-/ER+) Locally Advanced Inflammatory Breast Cancer (IBC) Patients
- Progression Free Survival (PFS) Rate of HER2+ Primary de novo Metastatic and Locally Advanced Inflammatory Breast Cancer (IBC) Patients, and HER2-/ER+ IBC Patients Treated with Neratinib Plus Anthracycline and Taxane Based Chemotherapy
|
99 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03101748 |
2016-0537
NCI-2017-00813 |
|
January 29, 2018 |
January 2026 |
January 2027 |
April 5, 2017 |
August 3, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 23 |
NCT00193206 |
Completed
Has Results |
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer |
|
- Drug: Gemcitabine
- Drug: Epirubicin
- Drug: Albumin-bound Paclitaxel
|
Interventional
|
Phase 2 |
- SCRI Development Innovations, LLC
- Eli Lilly and Company
- Celgene Corporation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic Complete Response
- Clinical Response Rates
- Time to Disease Progression
- Rates of Breast Preservation
|
123 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00193206 |
SCRI BRE 73 |
|
September 2005 |
October 2008 |
May 2009 |
September 19, 2005 |
November 30, 2012 |
November 30, 2012 |
- Florida Cancer Specialists
Fort Myers, Florida, United States - Integrated Community Oncology Network
Jacksonville, Florida, United States - Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, United States - (and 10 more...)
|
|
| 24 |
NCT00344071 |
Completed |
Pilot Study of Inflammatory Breast Cancer in Egypt and Tunisia |
- Inflammatory Breast Cancer
|
|
Observational
|
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
250 |
All |
Child, Adult, Older Adult |
NCT00344071 |
999904284
04-C-N284 |
|
September 8, 2004 |
April 27, 2007 |
|
June 26, 2006 |
July 2, 2017 |
|
- Cairo University Hospital
Cairo, Egypt - National Cancer Institute-Cairo
Cairo, Egypt - Association Tunisienne de lutte contre le Cancer (ATCC, le conseil
Tunis, Tunisia - Charles Nicolle Hospital, Tunisia
Tunis, Tunisia
|
|
| 25 |
NCT00340158 |
Completed |
Establishing an Inflammatory Breast Cancer Registry |
- Inflammatory Breast Cancer
|
|
Observational
|
|
- National Cancer Institute (NCI)
- United States Department of Defense
- National Institutes of Health Clinical Center (CC)
|
NIH / U.S. Fed |
- Time Perspective: Retrospective
|
|
164 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00340158 |
999903214
03-C-N214 |
|
June 2003 |
|
|
June 21, 2006 |
April 23, 2010 |
|
- National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 26 |
NCT00111787 |
Completed |
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer |
|
- Drug: Lapatinib
- Drug: Paclitaxel
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of participants with pathologic complete response rate (pCR)
- Percentage of participants with pCR that underwent surgical resection
- Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
- (and 11 more...)
|
49 |
All |
18 Years and older (Adult, Older Adult) |
NCT00111787 |
EGF102580 |
|
April 11, 2005 |
November 1, 2006 |
November 1, 2006 |
May 26, 2005 |
May 31, 2017 |
|
- GSK Investigational Site
Miami, Florida, United States - GSK Investigational Site
Chicago, Illinois, United States - GSK Investigational Site
Zion, Illinois, United States - (and 22 more...)
|
|
| 27 |
NCT00477100 |
Recruiting |
Inflammatory Breast Cancer (IBC) Registry |
|
- Other: Interview
- Procedure: Blood and Tissue Collection
|
Observational
|
|
- M.D. Anderson Cancer Center
- Susan G. Komen Breast Cancer Foundation
- M.D. Anderson Cancer Center
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Number of patients with untreated newly diagnosed IBC participating in Registry
|
1200 |
All |
18 Years and older (Adult, Older Adult) |
NCT00477100 |
2006-1072 |
|
April 2007 |
April 2020 |
April 2021 |
May 22, 2007 |
March 7, 2018 |
|
- City of Hope
Duarte, California, United States - University of New Mexico
Albuquerque, New Mexico, United States - University of Texas MD Anderson Cancer Center
Houston, Texas, United States - (and 16 more...)
|
|
| 28 |
NCT01231386 |
Recruiting |
MIRNA Profiling of Breast Cancer in Patients Undergoing Neoadjuvant or Adjuvant Treatment for Locally Advanced & Inflammatory Breast Cancer |
|
|
Observational
|
|
- City of Hope Medical Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Other
|
- Performance of miRNA profiling from tumor samples from primary breast tumors
- Assessment of miRNA profiles from blood/serum samples from patients at baseline, and if feasible, at different time points
- Analysis of miRNA findings and correlate miRNA patterns of expression in tumor, lymph nodes -if available- and in serum
- (and 4 more...)
|
165 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01231386 |
09147 |
|
November 2009 |
April 2019 |
April 2019 |
November 1, 2010 |
June 4, 2018 |
|
- City of Hope
Duarte, California, United States
|
|
| 29 |
NCT00105950 |
Completed |
Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response rate (complete response plus partial response)
- Clinical benefit (progression free survival, time to progression, response duration)
- Assessment of clinical benefit, defined as CR or PR for at least 4 weeks, or SD for at least 6 months
- (and 8 more...)
|
126 |
All |
18 Years and older (Adult, Older Adult) |
NCT00105950 |
EGF103009 |
|
March 2005 |
September 2007 |
May 2010 |
March 21, 2005 |
September 28, 2015 |
|
- GSK Investigational Site
Miami, Florida, United States - GSK Investigational Site
Chicago, Illinois, United States - GSK Investigational Site
Zion, Illinois, United States - (and 24 more...)
|
|
| 30 |
NCT00820547 |
Active, not recruiting |
Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients |
|
- Biological: bevacizumab
- Drug: cyclophosphamide
- Drug: docetaxel
- (and 2 more...)
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete histologic response rate
- Progression-free survival
- Overall survival
- (and 4 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT00820547 |
PACS09 UC-0140/0802
UNICANCER-PACS-09-0802
2008-001807-53 |
Beverly1 |
January 2009 |
April 2015 |
December 2018 |
January 12, 2009 |
October 15, 2018 |
|
- Centre Paul Papin
Angers, France - Institut Sainte Catherine
Avignon, France - Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besancon, France - (and 25 more...)
|
|
| 31 |
NCT00066443 |
Completed |
Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer |
|
- Biological: pegfilgrastim
- Drug: docetaxel
- Drug: epirubicin hydrochloride
|
Interventional
|
Phase 1
Phase 2 |
- NCIC Clinical Trials Group
- Canadian Cancer Trials Group
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Toxic effects
- Response (phase II)
|
93 |
Female |
16 Years and older (Child, Adult, Older Adult) |
NCT00066443 |
MA22
CAN-NCIC-MA22
CDR0000316237 |
|
February 2003 |
January 2014 |
January 2014 |
August 7, 2003 |
November 3, 2015 |
|
- CancerCare Manitoba
Winnipeg, Manitoba, Canada - Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada - Odette Cancer Centre
Toronto, Ontario, Canada - (and 2 more...)
|
|
| 32 |
NCT01796197 |
Active, not recruiting |
Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa |
|
- Drug: Trastuzumab
- Drug: Pertuzumab
- Drug: Paclitaxel
- (and 4 more...)
|
Interventional
|
Phase 2 |
- Dana-Farber Cancer Institute
- Dana-Farber Cancer Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic complete response rate
- Assess residual cancer burden
- Assess toxicity of protocol therapy
- (and 4 more...)
|
23 |
All |
18 Years and older (Adult, Older Adult) |
NCT01796197 |
12-497 |
|
March 2013 |
December 2018 |
March 2020 |
February 21, 2013 |
September 10, 2018 |
|
- Brigham and Women's Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - University of Michigan
Ann Arbor, Michigan, United States
|
|
| 33 |
NCT00193050 |
Completed
Has Results |
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer |
|
- Drug: Gemcitabine
- Drug: Epirubicin
- Drug: Docetaxel
|
Interventional
|
Phase 2 |
- SCRI Development Innovations, LLC
- Pharmacia and Upjohn
- Eli Lilly and Company
- Aventis Pharmaceuticals
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic Complete Response (pCR)
- Time to Treatment Failure (TTF)
- Overall Survival (OS)
|
110 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00193050 |
SCRI BRE 51 |
|
November 2001 |
March 2008 |
March 2009 |
September 19, 2005 |
September 21, 2012 |
September 21, 2012 |
|
|
| 34 |
NCT00251329 |
Unknown † |
Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery |
|
- Drug: neoadjuvant chemotherapy
|
Interventional
|
Phase 2 |
- Cancer Research Network
- Sanofi
- Cancer Research Network
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary objective of this study is to establish the pathological complete response rate (pCR) in the breast. The pCR is defined as the absence of invasive carcinoma.
- Establish pCR in breast and axillary lymph nodes
- Establish pCR in axillary lymph nodes
- (and 5 more...)
|
48 |
All |
18 Years and older (Adult, Older Adult) |
NCT00251329 |
CRN-004 |
|
May 2003 |
|
|
November 10, 2005 |
April 4, 2007 |
|
- Baptist Cancer Institute
Jacksonville, Florida, United States - Lakeland Regional Cancer Center
Lakeland, Florida, United States - Mount Sinai Comprehensice Cancer Center
Miami, Florida, United States - (and 3 more...)
|
|
| 35 |
NCT03742986 |
Not yet recruiting
New |
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC) |
|
- Drug: Nivolumab 360 mg+ paclitaxel 80 mg/m2
- Drug: Doxorubicin 60 mg/m2+Cyclophosphamide 600 mg/m2
- Drug: Nivolumab 360 mg+ Docetaxel* 75 mg/m2 +Trastuzumab 8 mg/kg +Pertuzumab 840 mg
- Drug: Doxorubicin 60 mg/m2 +Cyclophosphamide 600 mg/m2
|
Interventional
|
Phase 2 |
- New York University School of Medicine
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in pathological complete response (pCR)
|
52 |
All |
18 Years and older (Adult, Older Adult) |
NCT03742986 |
17-00890 |
|
April 2019 |
June 2025 |
June 2025 |
November 15, 2018 |
November 15, 2018 |
|
- NYU Langone Health
New York, New York, United States
|
|
| 36 |
NCT01036087 |
Active, not recruiting |
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer |
|
- Drug: Panitumumab
- Drug: Nab-paclitaxel
- Drug: Carboplatin
- (and 3 more...)
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- Celgene Corporation
- Amgen
- M.D. Anderson Cancer Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic Complete Response (CR) Rate
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT01036087 |
2008-0372
NCI-2012-00935 |
|
November 2010 |
November 2021 |
November 2021 |
December 21, 2009 |
November 14, 2018 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 37 |
NCT03184558 |
Recruiting |
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC |
- Triple Negative Breast Cancer
- Inflammatory Breast Cancer Stage IV
|
- Drug: Bemcentinib; pembrolizumab
|
Interventional
|
Phase 2 |
- BerGenBio ASA
- Merck Sharp & Dohme Corp.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate
- Disease Control Rate
- Duration of Response
- (and 3 more...)
|
56 |
All |
18 Years and older (Adult, Older Adult) |
NCT03184558 |
BGBC007
MK-3475 PN530
2016-003608-30 |
|
July 26, 2017 |
December 2018 |
December 2019 |
June 12, 2017 |
May 8, 2018 |
|
- City of Hope Cancer Center
Duarte, California, United States - Sharp memorial Hospital, 7901 Frost Street,
San Diego, California, United States - Saint Luke's Cancer Institute
Kansas City, Missouri, United States - (and 14 more...)
|
|
| 38 |
NCT00003680 |
Unknown † |
Standard Chemotherapy Compared With High-Dose Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Women With Advanced or Inflammatory Breast Cancer |
|
- Drug: CMF regimen
- Drug: cyclophosphamide
- Drug: fluorouracil
- (and 5 more...)
|
Interventional
|
Phase 3 |
- Scottish Cancer Therapy Network
- National Cancer Institute (NCI)
|
Other |
- Allocation: Randomized
- Primary Purpose: Treatment
|
|
300 |
Female |
18 Years to 60 Years (Adult) |
NCT00003680 |
CDR0000066782
SCTN-BR9810
EU-98054 |
|
November 1998 |
|
|
May 3, 2004 |
November 6, 2013 |
|
- C.R.C. Beatson Laboratories
Glasgow, Scotland, United Kingdom
|
|
| 39 |
NCT00513695 |
Active, not recruiting
Has Results |
Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer |
- Inflammatory Breast Cancer
- Male Breast Cancer
- Stage II Breast Cancer
- (and 3 more...)
|
- Drug: sunitinib malate
- Drug: paclitaxel
- Drug: doxorubicin hydrochloride
- (and 5 more...)
|
Interventional
|
Phase 2 |
- University of Washington
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Microscopic Pathologic CR (pCR) Rate
- Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels
- Relapse Rate
- (and 3 more...)
|
68 |
All |
Child, Adult, Older Adult |
NCT00513695 |
6488
NCI-2010-00607 |
|
June 2007 |
August 2012 |
|
August 9, 2007 |
August 21, 2018 |
May 10, 2017 |
- Anchorage Oncology Centre
Anchorage, Alaska, United States - Katmai Oncology Group
Anchorage, Alaska, United States - Arizona Cancer Center
Tucson, Arizona, United States - (and 4 more...)
|
|
| 40 |
NCT02041429 |
Active, not recruiting |
Ruxolitinib W/ Preop Chemo For Triple Negative Inflammatory Brca |
- Recurrent Breast Cancer
- Metastatic Breast Cancer
|
- Drug: Ruxolitinib
- Drug: Paclitaxel
|
Interventional
|
Phase 1
Phase 2 |
- Dana-Farber Cancer Institute
- Incyte Corporation
- Dana-Farber Cancer Institute
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose of ruxolitinib
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT02041429 |
13-494 |
|
January 27, 2014 |
May 2016 |
January 2021 |
January 22, 2014 |
November 2, 2018 |
|
- Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
|
| 41 |
NCT00017095 |
Completed |
Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer |
|
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: docetaxel
- (and 9 more...)
|
Interventional
|
Phase 3 |
- European Organisation for Research and Treatment of Cancer - EORTC
- Swedish Breast Cancer Group
- Swiss Group for Clinical Cancer Research
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival
- Distant metastasis-free survival
- Overall survival
- (and 5 more...)
|
1856 |
Female |
up to 70 Years (Child, Adult, Older Adult) |
NCT00017095 |
EORTC-10994-p53
EORTC-10994
ACCOG-EORTC-10994
SAKK-EORTC-10994
SBGC-EORTC-10994
BIG-1-00 |
|
March 2001 |
November 2006 |
|
January 27, 2003 |
October 24, 2013 |
|
- Institut Jules Bordet
Brussels, Belgium - CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium - Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium - (and 36 more...)
|
|
| 42 |
NCT02892734 |
Recruiting |
Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer |
- HER2/Neu Negative
- Recurrent Inflammatory Breast Carcinoma
- Stage IV Breast Cancer
- Stage IV Inflammatory Breast Carcinoma
|
- Biological: Ipilimumab
- Other: Laboratory Biomarker Analysis
- Biological: Nivolumab
|
Interventional
|
Phase 2 |
- Northwestern University
- Bristol-Myers Squibb
- National Cancer Institute (NCI)
|
Other / Industry / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival (PFS)
- Overall Response Rate (ORR)
- Clinical Benefit Rate (CBR)
- (and 2 more...)
|
29 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02892734 |
NU 16B07
STU00203191
P30CA060553
NCI-2016-01038 |
|
September 5, 2017 |
April 2019 |
September 2020 |
September 8, 2016 |
September 11, 2017 |
|
- Northwestern University
Chicago, Illinois, United States
|
|
| 43 |
NCT00001507 |
Completed |
Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer |
- Breast Neoplasm
- Neoplasm Metastasis
|
- Drug: Monoclonal Antibody 3A1
- Drug: Monoclonal Antibody 95-5-49
- Drug: Monoclonal Antibody 95-6-22
- (and 2 more...)
|
Interventional
|
Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
107 |
All |
18 Years and older (Adult, Older Adult) |
NCT00001507 |
960104
96-C-0104 |
|
July 12, 1996 |
June 30, 1998 |
June 20, 2014 |
November 4, 1999 |
October 6, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 44 |
NCT00957125 |
Unknown † |
A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early |
|
- Drug: Epirubicin
- Drug: Docetaxel
- Drug: Bevacizumab
|
Interventional
|
Phase 2 |
- Thomas Hatschek
- Karolinska University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluation of the sensitivity and of defined diagnostic and biological procedures to detect response/non-response to neoadjuvant treatment at an early point among patients with breast cancer.
- Identification of tumour characteristics and treatment-related changes of tumour characteristics predictive of long-term prognosis.
- Comparison between the standard evaluation procedures mammography, conventional ultrasound and clinical examination and functional imaging techniques and biological procedures with emphasis on detection of response at an early point of treatment.
- (and 3 more...)
|
151 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00957125 |
PROMIX
2007-005858-23 |
PROMIX |
September 2008 |
November 2011 |
November 2016 |
August 12, 2009 |
September 8, 2016 |
|
- Sahlgrenska University Hospital
Göteborg, Sweden - Lund University Hospital
Lund, Sweden - Malmö General University Hospital
Malmö, Sweden - (and 3 more...)
|
|
| 45 |
NCT00003679 |
Unknown † |
Combination Chemotherapy in Treating Women With Breast Cancer |
|
- Drug: cyclophosphamide
- Drug: docetaxel
- Drug: doxorubicin hydrochloride
- (and 3 more...)
|
Interventional
|
Phase 3 |
- Scottish Cancer Therapy Network
- National Cancer Institute (NCI)
|
Other |
- Allocation: Randomized
- Primary Purpose: Treatment
|
|
350 |
Female |
18 Years to 60 Years (Adult) |
NCT00003679 |
CDR0000066780
SCTN-BR9809
EU-98053 |
|
November 1998 |
|
|
December 5, 2003 |
November 6, 2013 |
|
- C.R.C. Beatson Laboratories
Glasgow, Scotland, United Kingdom
|
|
| 46 |
NCT00003042 |
Active, not recruiting |
Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer |
|
- Biological: filgrastim
- Drug: cisplatin
- Drug: cyclophosphamide
- (and 8 more...)
|
Interventional
|
Phase 2 |
- City of Hope Medical Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to progression at year 5
- Feasibility at year 5
- Overall survival at year 5
|
60 |
All |
up to 60 Years (Child, Adult) |
NCT00003042 |
96139
P30CA033572
CHNMC-96139
NCI-G97-1288
CDR0000065672 |
|
May 1997 |
March 2019 |
March 2019 |
January 27, 2003 |
October 9, 2018 |
|
- City of Hope Comprehensive Cancer Center
Duarte, California, United States
|
|
| 47 |
NCT00254592 |
Active, not recruiting
Has Results |
Neoadjuvant Treatment of Breast Cancer |
|
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- Drug: Carboplatin
- (and 4 more...)
|
Interventional
|
Phase 2 |
- University of California, Irvine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Clinical Response to the Dose Dense Regimen
|
43 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00254592 |
UCI 05-38
2005-4550 |
|
October 2005 |
September 4, 2013 |
December 28, 2018 |
November 16, 2005 |
February 9, 2018 |
November 11, 2013 |
- Chao Family Comprehensive Cancer Center
Orange, California, United States
|
|
| 48 |
NCT01894451 |
Active, not recruiting |
Pilot Study of Zirconium-89 Bevacizumab Positron Emission Tomography for Imaging Angiogenesis in Patients With Inflammatory Breast Carcinoma Receiving Preoperative Chemotherapy |
- Inflammatory Breast Carcinoma
|
- Drug: 89Zr-bevacizumab
- Procedure: FDG-PET/CT
- Procedure: MRI scan
- Procedure: Tumor biopsies
|
Interventional
|
Early Phase 1 |
- Dana-Farber Cancer Institute
- National Cancer Institute (NCI)
- Dana-Farber Cancer Institute
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Quality Control Standards for Radiopharmamceuticals and Number of Successfully Acquired 89Zr-bevacizumab-PET/CT scans
- Number of related adverse events after the intravenous administration of 89Zr-bevacizumab.
- Biodistribution of 89Zr-bevacizumab and individual organ and effective dose of 89Zr-bevacizumab
- (and 3 more...)
|
10 |
All |
21 Years and older (Adult, Older Adult) |
NCT01894451 |
13-147 |
|
June 2015 |
October 2019 |
October 2020 |
July 10, 2013 |
February 7, 2018 |
|
- Brigham and Womens Hospital
Boston, Massachusetts, United States - Dana Farber Cancer Institute
Boston, Massachusetts, United States
|
|
| 49 |
NCT02658812 |
Active, not recruiting |
Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery |
- Malignant Chest Wall Neoplasm
- Recurrent Breast Carcinoma
- Recurrent Inflammatory Breast Carcinoma
- (and 2 more...)
|
- Other: Laboratory Biomarker Analysis
- Biological: Talimogene Laherparepvec
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
- M.D. Anderson Cancer Center
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate defined as the percentage of complete response, partial response in overall patients
- Overall disease control rate
- Local overall response rate
- (and 4 more...)
|
35 |
All |
18 Years and older (Adult, Older Adult) |
NCT02658812 |
2014-0034
NCI-2016-00199
P30CA016672 |
|
August 1, 2016 |
August 1, 2021 |
August 1, 2021 |
January 20, 2016 |
November 6, 2018 |
|
- M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 50 |
NCT00049114 |
Completed |
Tipifarnib, Doxorubicin, and Cyclophosphamide in Treating Women With Locally Advanced Breast Cancer |
- Inflammatory Breast Cancer
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- (and 2 more...)
|
- Drug: doxorubicin hydrochloride
- Drug: cyclophosphamide
- Drug: tipifarnib
- (and 3 more...)
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response in the breast
- Proportion of patients who have a clinical complete response
- Grade 3 or 4 toxicities assessed using NCI CTCAE version 3.0
- (and 2 more...)
|
62 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00049114 |
NCI-2012-02500
02-05-125
AECM-0205125
NCI-5598
CDR0000257811
N01CM62204 |
|
February 2003 |
January 2007 |
|
January 27, 2003 |
June 6, 2013 |
|
- Albert Einstein College of Medicine
Bronx, New York, United States
|
|
| 51 |
NCT01206881 |
Completed |
Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer |
|
- Drug: pegylated liposomal doxorubicin
|
Interventional
|
Phase 2 |
- Herlev Hospital
- Rigshospitalet, Denmark
- Odense University Hospital
- Aarhus University Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- clinical response rate
- pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen
|
45 |
Female |
18 Years to 75 Years (Adult, Older Adult) |
NCT01206881 |
PO5903, EudraCT 2008-007951-29 |
|
March 2009 |
May 2011 |
June 2011 |
September 22, 2010 |
July 4, 2011 |
|
- Aarhus University Hospital
Aarhus, Denmark - Rigshospitalet
Copenhagen, Denmark - Herlev Hospital
Herlev, Denmark - Odense University Hospital
Odense, Denmark
|
|
| 52 |
NCT01525966 |
Recruiting |
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer |
- Inflammatory Breast Cancer
- Stage IIA Breast Cancer
- Stage IIIA Breast Cancer
- (and 7 more...)
|
- Drug: carboplatin
- Drug: paclitaxel albumin-stabilized nanoparticle formulation
- Other: laboratory biomarker analysis
|
Interventional
|
Phase 2 |
- City of Hope Medical Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pCR or Symmans 0-1 pathological response
- Overall survival
- Progression-free survival
- Number of patients experiencing serious adverse events (SAEs) graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
69 |
Female |
19 Years and older (Adult, Older Adult) |
NCT01525966 |
11174
NCI-2012-00025 |
|
February 15, 2012 |
February 2019 |
February 2019 |
February 3, 2012 |
August 17, 2018 |
|
- City of Hope Medical Center
Duarte, California, United States - City of Hope- South Pasadena Cancer Center
South Pasadena, California, United States
|
|
| 53 |
NCT00003199 |
Completed
Has Results |
Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer |
- Estrogen Receptor-negative Breast Cancer
- Estrogen Receptor-positive Breast Cancer
- Inflammatory Breast Cancer
- (and 5 more...)
|
- Drug: tamoxifen citrate
- Drug: busulfan
- Drug: thiotepa
- (and 5 more...)
|
Interventional
|
Phase 2 |
- Fred Hutchinson Cancer Research Center
- National Cancer Institute (NCI)
- Fred Hutchinson Cancer Research Center
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Event-free Survival
- Overall Survival
- Number of Participants With Toxicity of a Combination of Low-dose IL-2 and GM-CSF
|
50 |
All |
19 Years to 65 Years (Adult, Older Adult) |
NCT00003199 |
PSOC 1605
NCI-2010-00728 |
|
November 1997 |
December 2009 |
December 2009 |
January 27, 2003 |
July 12, 2017 |
May 17, 2017 |
- Fred Hutchinson Cancer Research Center/Puget Sound Oncology Consortium
Seattle, Washington, United States
|
|
| 54 |
NCT02124902 |
Recruiting |
Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity |
- Triple Negative Breast Neoplasms
|
- Drug: Docetaxel
- Drug: Carboplatin
|
Interventional
|
Phase 2 |
- Washington University School of Medicine
|
Other |
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological Complete Response (pCR) rate
|
89 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02124902 |
201404107 |
|
July 7, 2014 |
May 31, 2019 |
May 31, 2019 |
April 28, 2014 |
October 12, 2018 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
|
| 55 |
NCT02003209 |
Active, not recruiting |
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer |
- Estrogen Receptor Positive
- HER2/Neu Positive
- Progesterone Receptor Positive
- (and 6 more...)
|
- Drug: Aromatase Inhibition Therapy
- Drug: Carboplatin
- Other: Cytology Specimen Collection Procedure
- (and 8 more...)
|
Interventional
|
Phase 3 |
- National Cancer Institute (NCI)
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of pCR in the breast and post therapy lymph nodes
- Rate of pCR in the breast
- RFI
- (and 10 more...)
|
312 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02003209 |
NCI-2013-02228
NSABP-B-52
U10CA012027
U10CA180868 |
|
January 15, 2014 |
August 31, 2021 |
|
December 6, 2013 |
October 18, 2018 |
|
- Fairbanks Memorial Hospital
Fairbanks, Alaska, United States - CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, United States - Kaiser Permanente-Anaheim
Anaheim, California, United States - (and 737 more...)
|
|
| 56 |
NCT00004925 |
Completed |
Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer |
|
- Biological: trastuzumab
- Drug: pegylated liposomal doxorubicin hydrochloride
|
Interventional
|
Phase 1
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
- Memorial Sloan Kettering Cancer Center
|
Other / NIH |
- Primary Purpose: Treatment
|
|
|
Female |
18 Years and older (Adult, Older Adult) |
NCT00004925 |
99-054
CDR0000067609
LIPO-D9905
NCI-G00-1684 |
|
August 1999 |
August 2003 |
August 2003 |
May 14, 2003 |
June 19, 2013 |
|
- Memorial Sloan-Kettering Cancer Center
New York, New York, United States
|
|
| 57 |
NCT00499122 |
Completed
Has Results |
NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer |
|
- Drug: Cyclophosphamide
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: NOV 002
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy
- Definition of the Safety Profiles of Protocol Therapy
- Correlation Between Myeloid Derived Suppressor Cell (MDSC) Levels and Pathologic Complete Response (pCR) and Non-Responders
|
41 |
Female |
18 Years to 120 Years (Adult, Older Adult) |
NCT00499122 |
20071167
MUSC-101072
MUSC-HR-17111 |
|
June 4, 2007 |
April 2011 |
April 2011 |
July 11, 2007 |
January 2, 2018 |
March 29, 2013 |
- University of Miami
Miami, Florida, United States - Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
|
|
| 58 |
NCT00005800 |
Completed |
Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer |
|
- Biological: Filgrastim
- Drug: Docetaxel
- Drug: Doxorubicin
- Procedure: Surgery
|
Interventional
|
Phase 2 |
- H. Lee Moffitt Cancer Center and Research Institute
- National Cancer Institute (NCI)
- Aventis Pharmaceuticals
- H. Lee Moffitt Cancer Center and Research Institute
|
Other / NIH / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological Response Rate
|
45 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT00005800 |
MCC-11971
CA 82533 |
|
April 1999 |
January 2006 |
May 2012 |
October 8, 2003 |
September 25, 2012 |
|
- H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
|
|
| 59 |
NCT02879513 |
Recruiting |
Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy |
- Invasive Ductal Breast Cancer
- Tubular Breast Cancer
- Mucinous Breast Cancer
- Inflammatory Breast Cancer
|
- Drug: Paclitaxel
- Drug: Cisplatin
- Drug: Epirubicin
- (and 2 more...)
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease-free survival (DFS)
- overall survival (OS)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- (and 3 more...)
|
290 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT02879513 |
RenJiH-BC-003 |
|
January 2014 |
December 2018 |
December 2022 |
August 25, 2016 |
August 15, 2018 |
|
- Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai, China
|
|
| 60 |
NCT02227082 |
Recruiting |
Olaparib and Radiotherapy in Inoperable Breast Cancer |
- Locally Advanced Malignant Neoplasm
- Inflammatory Breast Carcinoma
- Triple-Negative Invasive Breast Carcinoma
|
- Radiation: radiotherapy
- Drug: olaparib
|
Interventional
|
Phase 1 |
- The Netherlands Cancer Institute
- The Netherlands Cancer Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The incidence of dose limiting toxicities.
- Acute toxicity
- Late toxicity
|
36 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02227082 |
N13ORB
2011-001586-40 |
|
October 21, 2013 |
January 2019 |
August 2020 |
August 27, 2014 |
March 13, 2018 |
|
- The Netherlands Cancer Institute
Amsterdam, Netherlands
|
|
| 61 |
NCT00162812 |
Terminated |
Topoisomerase II Alpha Gene Amplification and Protein Overexpression Predicting Efficacy of Epirubicin |
|
|
Interventional
|
Phase 2 |
- Jules Bordet Institute
- Gustave Roussy, Cancer Campus, Grand Paris
- Centre Paul Strauss
- (and 7 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- correlation of topoisomerase II and pathologic complete response
|
338 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT00162812 |
TOP Trial
CE1141 |
TOP |
January 2003 |
December 2008 |
April 2009 |
September 13, 2005 |
July 18, 2008 |
|
- Jules Bordet Institute
Brussels, Belgium
|
|
| 62 |
NCT00008034 |
Completed |
Combination Chemotherapy Before Surgery in Treating Women With Breast Cancer |
|
- Drug: capecitabine
- Drug: cyclophosphamide
- Drug: epirubicin hydrochloride
|
Interventional
|
Phase 1 |
- European Organisation for Research and Treatment of Cancer - EORTC
- European Organisation for Research and Treatment of Cancer - EORTC
|
Other |
- Primary Purpose: Treatment
|
|
15 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT00008034 |
EORTC-10991
IDBBC-10991-CEX |
|
February 2000 |
December 2000 |
|
February 3, 2004 |
July 18, 2012 |
|
- Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland
|
|
| 63 |
NCT00986609 |
Completed |
MUC1 Vaccine for Triple-negative Breast Cancer |
- Breast Cancer
- Inflammatory Breast Cancer
- Stage I Breast Cancer
- (and 5 more...)
|
- Biological: MUC-1 peptide vaccine
- Biological: poly ICLC
- Biological: MUC1 peptide-poly-ICLC adjuvant vaccine
- (and 3 more...)
|
Interventional
|
Early Phase 1 |
- Joseph Baar, MD, PhD
- Case Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Proportion of patients showing a positive anti-MUC1 antibody response
- Safety and toxicity as assessed by NCI CTC
|
29 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00986609 |
CASE16107
NCI-2009-01318 |
|
August 19, 2009 |
August 29, 2013 |
January 21, 2016 |
September 30, 2009 |
July 23, 2018 |
|
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
|
| 64 |
NCT00016406 |
Completed |
S0012 Doxorubicin, Cyclophosphamide, and Paclitaxel With or Without Filgrastim in Treating Women With Inflammatory or Locally Advanced Breast Cancer |
|
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: doxorubicin
- (and 2 more...)
|
Interventional
|
Phase 3 |
- Southwest Oncology Group
- National Cancer Institute (NCI)
- Southwest Oncology Group
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Comparison of microscopic pathologic response rates
- Toxicity
- Comparison of delivered dose intensity
- Correlation of microscopic pathologic complete response with clinical complete response at the primary tumor site
|
399 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00016406 |
CDR0000068630
S0012
U10CA032102 |
|
May 2001 |
September 2006 |
February 2012 |
January 27, 2003 |
January 24, 2013 |
|
- Mobile Infirmary Medical Center
Mobile, Alabama, United States - Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States - Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States - (and 311 more...)
|
|
| 65 |
NCT00856492 |
Completed
Has Results |
S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer |
|
- Biological: bevacizumab
- Biological: pegfilgrastim
- Drug: cyclophosphamide
- (and 2 more...)
|
Interventional
|
Phase 2 |
- Southwest Oncology Group
- National Cancer Institute (NCI)
- Southwest Oncology Group
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With Pathological Complete Response Rate
- Overall Survival
- Event-free Survival
- Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug
|
215 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00856492 |
CDR0000636131
S0800
U10CA032102 |
|
April 2010 |
October 2015 |
December 2015 |
March 5, 2009 |
June 27, 2017 |
June 27, 2017 |
- Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States - Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States - (and 363 more...)
|
|
| 66 |
NCT00450892 |
Completed |
Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer |
|
- Drug: docetaxel+lapatinib
- Drug: docetaxel + trastuzumab
- Drug: docetaxel + trastuzumab + lapatinib
|
Interventional
|
Phase 1
Phase 2 |
- European Organisation for Research and Treatment of Cancer - EORTC
- GlaxoSmithKline
- European Organisation for Research and Treatment of Cancer - EORTC
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I part: Dose limiting toxicity during cycle 1
- Phase II: Pathological complete response rate
- Phase I: Changes in apoptosis and proliferation markers.
- Phase II: Tolerability, clinical/radiological response rates, breast conserving surgery, pharmacodynamics data
|
129 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT00450892 |
EORTC-10054
GSK-EORTC-10054
2006-000864-94 |
|
February 2007 |
July 2013 |
July 2013 |
March 22, 2007 |
July 7, 2016 |
|
- C.H.U. Sart-Tilman
Liege, Belgium - Clinique Sainte Elisabeth
Namur, Belgium - Institut Bergonie
Bordeaux, France - (and 12 more...)
|
|
| 67 |
NCT01426880 |
Completed |
Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer |
- Tubular Breast Cancer Stage II
- Mucinous Breast Cancer Stage II
- Breast Cancer Female NOS
- (and 5 more...)
|
- Drug: Carboplatin
- Drug: background treatment
|
Interventional
|
Phase 2
Phase 3 |
- German Breast Group
- Teva Pharmaceuticals USA
- Roche Pharma AG
- (and 2 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response of breast and lymph nodes (ypT0 ypN0; primary endpoint)
- 1.ypT0/is ypN0; ypT0; ypT0/is; ypN0, and regression grades
- Clinical and imaging response
- (and 11 more...)
|
595 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01426880 |
GBG 66
2011-000553-23 |
GeparSixto |
August 2011 |
May 2013 |
August 2013 |
September 1, 2011 |
February 15, 2016 |
|
- Praxis Dr. Heinrich
Fürstenwalde, Brandenburg, Germany - Luisenkrankenhaus
Düsseldorf, Nordrhein-Westfalen, Germany - NCT Heidelberg
Heidelberg, Germany
|
|
| 68 |
NCT00559845 |
Completed
Has Results |
A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer |
|
- Drug: 5-fluorouracil
- Drug: Epidoxorubicin
- Drug: Cyclophosphamide
- (and 2 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
- Objective Response Rate
- Percentage of Participants With Breast-Conserving Surgery
- (and 3 more...)
|
56 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00559845 |
ML19884
2006-003291-35 |
|
February 2008 |
July 2015 |
July 2015 |
November 16, 2007 |
April 9, 2018 |
April 9, 2018 |
- Napoli, Campania, Italy
- Reggio Emilia, Emilia-Romagna, Italy
- Pordenone, Friuli-Venezia Giulia, Italy
- (and 5 more...)
|
|
| 69 |
NCT01583426 |
Active, not recruiting |
Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto) |
- Tubular Breast Cancer Stage II
- Mucinous Breast Cancer Stage II
- Breast Cancer Female NOS
- (and 5 more...)
|
- Drug: nab-Paclitaxel
- Drug: Paclitaxel
|
Interventional
|
Phase 3 |
- German Breast Group
- Celgene Corporation
- Roche Pharma AG
- German Breast Group
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.
- Rates of ypT0/is ypN0; ypT0 ypN0/+; ypT0/is ypN0/+; ypT(any) ypN0, and regression grade
- Clinical and imaging response
- (and 16 more...)
|
1200 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01583426 |
GBG 69
2011-004714-41 |
GeparSepto |
July 2012 |
December 2018 |
December 2018 |
April 24, 2012 |
October 12, 2016 |
|
- Helios-Klinikum Berlin-Buch
Berlin, Germany
|
|
| 70 |
NCT02286583 |
Unknown † |
Medical Radiometer - RTM - 01 - RES and Its Use in Detecting Hotspots in Female Breast |
|
- Device: Microwave Thermography RTM-01-RES
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Testing the sensitivity of the Microwave Thermography RTM-01-RES (ability to detect hotspots in breast lesions)
- Study the Temperature pattern
|
2000 |
Female |
Child, Adult, Older Adult |
NCT02286583 |
LabdomSuisseRD |
RTM |
February 2015 |
May 2015 |
October 2015 |
November 10, 2014 |
April 1, 2015 |
|
- Poliklinik Permai Tanjumg Aru
Kota Kinabalu, Sabah, Malaysia
|
|
| 71 |
NCT00397761 |
Unknown † |
Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer |
|
- Drug: capecitabine
- Drug: paclitaxel albumin-stabilized nanoparticle formulation
- Procedure: neoadjuvant therapy
|
Interventional
|
Phase 2
Phase 3 |
- Washington Hospital Center
- National Cancer Institute (NCI)
|
Other |
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response rate
- Safety
- Overall clinical response rate
|
33 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00397761 |
CDR0000513169
WHC-MRI-GU-2006-097 |
|
July 2006 |
|
|
November 9, 2006 |
February 9, 2009 |
|
- Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States
|
|
| 72 |
NCT00310089 |
Completed |
AZD2171 and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer |
|
- Biological: filgrastim
- Biological: pegfilgrastim
- Drug: cediranib maleate
- (and 6 more...)
|
Interventional
|
Not Applicable |
- National Cancer Institute (NCI)
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Primary Purpose: Treatment
|
|
33 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00310089 |
CDR0000466185
NCI-06-C-0057
NCI-7088 |
|
January 2006 |
|
July 2007 |
April 3, 2006 |
June 20, 2013 |
|
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States - Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
|
|
| 73 |
NCT00028704 |
Terminated |
Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy |
|
- Procedure: conventional surgery
- Radiation: radiation therapy
|
Interventional
|
Phase 3 |
- European Organisation for Research and Treatment of Cancer - EORTC
- Central and Eastern European Oncology Group
- Grupo Oncologico Cooperativo Chileno de Investigation
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Primary Purpose: Treatment
|
|
26 |
Female |
Child, Adult, Older Adult |
NCT00028704 |
EORTC-10974-22002
EORTC-10974
CEEOG-EORTC-10974
EORTC-22002
GOCCHI-EORTC-10974
ICCG-EORTC-10974
EORTC-BIG-0002
LAMANOMA |
|
October 2001 |
December 2003 |
|
January 27, 2003 |
July 18, 2012 |
|
- Centre Hospitalier Etterbeek Ixelles
Brussels, Belgium - U.Z. Gasthuisberg
Leuven, Belgium - Instituto de Radiomedicina
Santiago, Chile - (and 10 more...)
|
|
| 74 |
NCT00002616 |
Unknown † |
Biological Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer |
|
- Biological: aldesleukin
- Biological: filgrastim
- Drug: carboplatin
- (and 3 more...)
|
Interventional
|
Phase 1 |
- University of Illinois at Chicago
- National Cancer Institute (NCI)
|
Other |
- Primary Purpose: Treatment
|
|
36 |
All |
up to 64 Years (Child, Adult) |
NCT00002616 |
CDR0000063925
UIC-95-1011
LUMC-6728
NCI-V94-0573 |
|
February 1995 |
|
|
August 31, 2004 |
September 20, 2013 |
|
- University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, United States
|
|
| 75 |
NCT00002627 |
Unknown † |
Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer |
|
- Biological: filgrastim
- Drug: carboplatin
- Drug: cyclophosphamide
- (and 3 more...)
|
Interventional
|
Phase 1
Phase 2 |
- St. Louis University
- National Cancer Institute (NCI)
|
Other |
- Primary Purpose: Treatment
|
|
30 |
Female |
18 Years to 65 Years (Adult, Older Adult) |
NCT00002627 |
CDR0000064016
SLUMC-8038
NCI-V95-0607 |
|
November 1994 |
|
|
July 29, 2004 |
January 10, 2014 |
|
- St. Louis University Health Sciences Center
Saint Louis, Missouri, United States
|
|
| 76 |
NCT01641406 |
Unknown † |
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer" |
- Infiltrating Duct and Lobular Carcinoma In Situ
- Invasive Lobular Breast Carcinoma
- Inflammatory Breast Carcinoma
|
- Drug: Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab
|
Interventional
|
Phase 2 |
- Auxilio Mutuo Cancer Center
- Auxilio Mutuo Cancer Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary objective is to obtain a RCB rate of 0-1 in at least 66%
|
60 |
Female |
18 Years and older (Adult, Older Adult) |
NCT01641406 |
NAC CCAM 11-01 |
NACprotocol |
March 2011 |
January 2013 |
March 2013 |
July 16, 2012 |
July 16, 2012 |
|
- Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
|
|
| 77 |
NCT00182793 |
Completed
Has Results |
Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer |
|
- Biological: trastuzumab
- Drug: carboplatin
- Drug: cyclophosphamide
- (and 6 more...)
|
Interventional
|
Phase 2 |
- City of Hope Medical Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 5-Year Relapse-free Survival Rate
- 5-Year Overall Survival Rate
|
32 |
All |
up to 65 Years (Child, Adult, Older Adult) |
NCT00182793 |
05042
P30CA033572
CDR0000442105 |
|
July 2005 |
October 2014 |
October 2014 |
September 16, 2005 |
February 23, 2017 |
February 23, 2017 |
- City of Hope Comprehensive Cancer Center
Duarte, California, United States
|
|
| 78 |
NCT00001193 |
Completed |
A Multimodality Treatment Approach to Patients With Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer |
- Breast Neoplasms
- Neoplasm Metastasis
|
- Procedure: high dose melphalan and autologous bone marrow transplantation
|
Interventional
|
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
200 |
All |
Child, Adult, Older Adult |
NCT00001193 |
840216
84-C-0216 |
|
November 1984 |
|
September 2000 |
December 10, 2002 |
March 4, 2008 |
|
- National Cancer Institute (NCI)
Bethesda, Maryland, United States
|
|
| 79 |
NCT00005058 |
Unknown † |
Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer |
|
- Procedure: ultrasound imaging
|
Interventional
|
Not Applicable |
- Royal Marsden NHS Foundation Trust
- National Cancer Institute (NCI)
|
Other |
- Primary Purpose: Diagnostic
|
|
|
Female |
18 Years and older (Adult, Older Adult) |
NCT00005058 |
CDR0000067655
RMNHS-1443
EU-20003 |
|
August 1997 |
|
|
April 12, 2004 |
November 6, 2013 |
|
- Royal Marsden NHS Trust
London, England, United Kingdom
|
|
| 80 |
NCT03109080 |
Recruiting |
Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC) |
- Breast Neoplasms, Triple-Negative
- Breast Neoplasm Malignant Female
- Radiotherapy Side Effect
|
- Drug: Olaparib
- Radiation: Radiation therapy
|
Interventional
|
Phase 1 |
- Institut Curie
- AstraZeneca
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determination of the Maximal Tolerated Dose of Olaparib administered with concurrent loco regional radiotherapy
- Incidence of Serious Adverse Events (SAEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
- Incidence and severity of Adverse Events (AEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
- (and 13 more...)
|
24 |
Female |
18 Years and older (Adult, Older Adult) |
NCT03109080 |
IC 2016-01 RadioPARP
2016-001837-28 |
RadioPARP |
July 24, 2017 |
July 2019 |
July 2021 |
April 12, 2017 |
October 12, 2018 |
|
- Institut Curie
Paris, France
|
|
| 81 |
NCT00891280 |
Unknown † |
Dose-escalation Study of Oral CX-4945 |
- Advanced Solid Tumors
- Breast Cancer
- Inflammatory Breast Cancer
- (and 2 more...)
|
- Drug: CX-4945 oral formulation
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety (Dose limiting toxicities, maximum tolerated dose)
- Drug-related adverse events
- Pharmacokinetic and pharmacodynamic assessments
- (and 2 more...)
|
55 |
All |
18 Years and older (Adult, Older Adult) |
NCT00891280 |
C4-08-001 |
|
February 2009 |
December 2011 |
December 2011 |
May 1, 2009 |
June 15, 2011 |
|
- Mayo Clinic Arizona
Scottsdale, Arizona, United States - Front Range Cancer Specialists
Fort Collins, Colorado, United States - Front Range Cancer Specialists
Loveland, Colorado, United States - U T M D Anderson Cancer Center
Houston, Texas, United States
|
|
| 82 |
NCT00295893 |
Active, not recruiting |
Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer |
|
- Biological: trastuzumab
- Drug: carboplatin
- Drug: cyclophosphamide
- (and 3 more...)
|
Interventional
|
Phase 2 |
- City of Hope Medical Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete response rate
- Feasibility
- Quality of life and neuropathy assessment of prognostic and predictive markers as measured by FACT exploratory methods at 1 year
|
105 |
All |
18 Years to 120 Years (Adult, Older Adult) |
NCT00295893 |
05015
P30CA033572
CDR0000455631 |
|
September 14, 2005 |
January 2019 |
January 2019 |
February 24, 2006 |
October 31, 2018 |
|
- City of Hope Medical Center
Duarte, California, United States
|
|
| 83 |
NCT02199418 |
Completed |
Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer |
- Tubular Breast Cancer
- Mucinous Breast Cancer
- Invasive Ductal Breast Cancer
- Inflammatory Breast Cancer
|
- Drug: Paclitaxel
- Drug: Cisplatin
|
Interventional
|
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response of breast and lymph nodes
- Tolerability and Safety
- Clinical and imaging response
- (and 4 more...)
|
132 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT02199418 |
RenJiH-BC-001 |
SHPD001 |
January 2013 |
November 2015 |
October 2016 |
July 24, 2014 |
January 25, 2017 |
|
- Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China - Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai, China
|
|
| 84 |
NCT00545688 |
Completed
Has Results |
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer. |
|
- Drug: Herceptin
- Drug: Docetaxel
- Drug: Pertuzumab
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving Pathological Complete Response (pCR)
- Percentage of Participants Achieving pCR by Breast Cancer Type
- Percentage of Participants Achieving pCR by Hormone Receptor Status
- (and 13 more...)
|
417 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00545688 |
WO20697 |
|
June 26, 2006 |
September 22, 2014 |
September 22, 2014 |
October 17, 2007 |
August 15, 2017 |
January 26, 2016 |
- Geelong Hospital; Andrew Love Cancer Centre
Geelong, Victoria, Australia - Mount Medical Center
Perth, Western Australia, Australia - Kaiser Franz Josef Spital; Iii. Medizinische Abt. Mit Onkologie
Vienna, Austria - (and 74 more...)
|
|
| 85 |
NCT02221999 |
Recruiting |
Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients |
- Tubular Breast Cancer
- Mucinous Breast Cancer
- Invasive Ductal Breast Cancer
- Inflammatory Breast Cancer
|
- Drug: Paclitaxel
- Drug: Cisplatin
- Drug: Gonadotropin-releasing hormone agonist
- Drug: Letrozole
|
Interventional
|
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pathological complete remission rate
- Number of Participants With Drug Related Treatment Adverse Events
- Clinical and imaging response
- (and 7 more...)
|
250 |
Female |
18 Years to 70 Years (Adult, Older Adult) |
NCT02221999 |
RenJiH-BC-002 |
SHPD002 |
January 2014 |
October 2018 |
October 2022 |
August 21, 2014 |
August 15, 2018 |
|
- HanDan Central Hospital
Handan, Hebei, China - The First Affiliated Hospital of University of South China
Hengyang, Hunan, China - The second people's hospital of Kunshan city
Kunshan, Jiangsu, China - (and 5 more...)
|
|
| 86 |
NCT00343512 |
Terminated
Has Results |
Docetaxel Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer |
|
- Drug: docetaxel
- Genetic: protein expression analysis
- Other: laboratory biomarker analysis
- (and 3 more...)
|
Interventional
|
Phase 2 |
- Vanderbilt-Ingram Cancer Center
- National Cancer Institute (NCI)
- Vanderbilt-Ingram Cancer Center
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number Participants to Achieve Pathologic Complete Response
- Safety Profile Based on Number of Patients With Each Worst-grade Toxicity
- Tumor Response as Measured by Ultrasound
|
34 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00343512 |
VICC BRE 0368
VICC-BRE-0368
VICC-11239 |
|
February 2004 |
March 2008 |
March 2011 |
June 23, 2006 |
April 27, 2012 |
November 9, 2010 |
- Meharry Medical College
Nashville, Tennessee, United States - Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
|
|
| 87 |
NCT00398489 |
Unknown † |
Docetaxel, Epirubicin, and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery |
|
- Biological: trastuzumab
- Drug: anastrozole
- Drug: cyclophosphamide
- (and 8 more...)
|
Interventional
|
Phase 2 |
- Technische Universität München
- National Cancer Institute (NCI)
|
Other |
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer
- Rate of pCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer
- Tolerability of treatment as measured by the nature and frequency of adverse events in women with HER2-positive or HER2-negative disease
- (and 7 more...)
|
94 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00398489 |
CDR0000516034
KRDI-TUM-HED-324-PAE-0090-I
EU-20634
EUDRACT-2005-000967-24 |
|
October 2006 |
|
|
November 10, 2006 |
November 9, 2010 |
|
- Klinikum Bayreuth
Bayreuth, Germany - Universitaetsfrauenklinik - Koeln
Cologne, Germany - Klinikum Deggendorf
Deggendorf, Germany - (and 2 more...)
|
|
| 88 |
NCT00916578 |
Completed
Has Results |
Xeloda (Capecitabine) and External Beam Radiation |
|
- Radiation: Radiation Therapy
- Drug: Capecitabine
|
Interventional
|
Phase 2 |
- M.D. Anderson Cancer Center
- M.D. Anderson Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Response Rate of Patients Who Receive Pre-operative or Palliative Concurrent Radiation w/ Capecitabine to the Breast & at Risk or Involved Regional Lymph Nodes Basins.
|
33 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00916578 |
2009-0087
NCI-2012-01266 |
|
June 5, 2009 |
June 6, 2017 |
June 6, 2017 |
June 9, 2009 |
July 25, 2018 |
June 28, 2018 |
- UT MD Anderson Cancer Center
Houston, Texas, United States
|
|
| 89 |
NCT00016276 |
Terminated |
Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer |
- Cardiac Toxicity
- Inflammatory Breast Cancer
- Stage IIIA Breast Cancer
- (and 2 more...)
|
- Drug: dexrazoxane hydrochloride
- Drug: doxorubicin hydrochloride
- Drug: cyclophosphamide
- (and 6 more...)
|
Interventional
|
Phase 3 |
- National Cancer Institute (NCI)
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Median number of positive axillary lymph nodes
- Pathologic complete response (CR) rate in the breast and axilla
- Cardiac toxicity, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
- (and 8 more...)
|
396 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00016276 |
NCI-2012-02380
CLB-49808
U10CA031946
CDR0000068617 |
|
May 2001 |
March 2005 |
|
September 4, 2003 |
January 16, 2013 |
|
- Cancer and Leukemia Group B
Chicago, Illinois, United States
|
|
| 90 |
NCT00717405 |
Completed
Has Results |
A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer. |
|
- Drug: Standard chemotherapy
- Drug: bevacizumab [Avastin]
- Drug: trastuzumab [Herceptin]
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification
- Percentage of Participants With a PCR According to the Chevallier Classification
- Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit
- (and 11 more...)
|
52 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00717405 |
ML21531
2008-000783-16 |
|
October 2008 |
April 2010 |
October 2014 |
July 17, 2008 |
August 2, 2016 |
January 6, 2016 |
- Besancon, France
- Bordeaux, France
- Brest, France
- (and 25 more...)
|
|
| 91 |
NCT02125344 |
Completed |
A Phase III Trial Comparing Two Dose-dense, Dose-intensified Approaches (ETC and PM(Cb)) for Neoadjuvant Treatment of Patients With High-risk Early Breast Cancer (GeparOcto) |
- Tubular Breast Cancer Stage II
- Tubular Breast Cancer Stage III
- Mucinous Breast Cancer Stage II
- (and 4 more...)
|
- Drug: non-pegylated liposomal doxorubicin
- Drug: Carboplatin
- Drug: Paclitaxel
- (and 5 more...)
|
Interventional
|
Phase 3 |
- German Breast Group
- Amgen
- Roche Pharma AG
- (and 3 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pathological complete response (pCR= ypT0/is ypN0)
- Only for those patients randomized for the supportive anemia treatment: frequency of patients reaching hemoglobin (Hb) levels ≥ 11g/dl 6 weeks after treatment start of a first episode of anemia grade ≥2
- pcR rates per arm
- (and 19 more...)
|
961 |
Female |
18 Years and older (Adult, Older Adult) |
NCT02125344 |
GBG 84 |
|
December 2014 |
November 2016 |
January 30, 2017 |
April 29, 2014 |
July 13, 2017 |
|
- NTC
Heidelberg, Baden-Württemberg, Germany
|
|
| 92 |
NCT00070252 |
Completed |
Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer |
- Adult Solid Neoplasm
- Inflammatory Breast Carcinoma
- Male Breast Carcinoma
- (and 2 more...)
|
- Drug: Capecitabine
- Drug: Docetaxel
- Other: Laboratory Biomarker Analysis
- (and 2 more...)
|
Interventional
|
Phase 1
Phase 2 |
- National Cancer Institute (NCI)
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose-limiting toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Phase I)
- Pathologic complete response rate (Phase II)
- Clinical tumor response (complete response [CR] or partial response [PR]) (Phase I)
- (and 2 more...)
|
53 |
All |
18 Years and older (Adult, Older Adult) |
NCT00070252 |
NCI-2012-01442
WSU-C-2679
MAYO-MC0131
NCI-5599
CDR0000331694
MC0131
5599
N01CM62205
P30CA015083 |
|
September 2003 |
February 2006 |
June 2010 |
October 7, 2003 |
May 4, 2015 |
|
- Mayo Clinic in Arizona
Scottsdale, Arizona, United States - Howard University Cancer Center CCOP
Washington, District of Columbia, United States - Mayo Clinic in Florida
Jacksonville, Florida, United States - (and 4 more...)
|
|
| 93 |
NCT01038258 |
Unknown † |
Monitoring Response After The First Chemotherapy Cycle After Neoadjuvant Breast Cancer Therapy |
- Invasive Ductal Carcinoma
- Lobular Breast Carcinoma
- Inflammatory Breast Carcinoma
|
- Procedure: PET scan after course 1 and surgery after 8 courses
|
Interventional
|
Not Applicable |
- Auxilio Mutuo Cancer Center
- Sononuclear
- Auxilio Mutuo Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT01038258 |
CCAM 07 |
PETBreast |
July 2007 |
December 2011 |
April 2013 |
December 23, 2009 |
July 13, 2012 |
|
- Hospital Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
|
|
| 94 |
NCT00006110 |
Completed
Has Results |
Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer |
|
- Biological: trastuzumab
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- (and 2 more...)
|
Interventional
|
Phase 2 |
- UNC Lineberger Comprehensive Cancer Center
- UNC Lineberger Comprehensive Cancer Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cardiac Toxicity of Weekly Taxol Given With Weekly Herceptin When Delivered Immediately Following Four Cycles of Standard Dose AC.
- Overall Response
- Disease-free Survival (DFS) in Patients Receiving and Not Receiving Herceptin®.
|
82 |
Female |
1 Year to 120 Years (Child, Adult, Older Adult) |
NCT00006110 |
LCCC 9818
LCCC9818
NCI-G00-1836 |
NRR |
December 1998 |
March 2012 |
April 2013 |
January 27, 2003 |
July 31, 2017 |
July 31, 2017 |
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States - Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
|
|
| 95 |
NCT00976989 |
Completed
Has Results |
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer |
|
- Drug: Pertuzumab
- Drug: Trastuzumab
- Drug: FEC
- (and 2 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator
- Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
- Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
- (and 9 more...)
|
225 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00976989 |
BO22280
2009-012019-17 |
|
November 2009 |
June 2011 |
January 2016 |
September 15, 2009 |
February 6, 2017 |
June 20, 2016 |
- Nassau, Bahamas
- Banja Luka, Bosnia and Herzegovina
- Sarajevo, Bosnia and Herzegovina
- (and 52 more...)
|
|
| 96 |
NCT02132949 |
Active, not recruiting
Has Results |
A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer |
|
- Drug: 5-Fluorouracil
- Drug: Cyclophosphamide
- Drug: Docetaxel
- (and 5 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants With New York Heart Association (NYHA) Class III and IV Heart Failure During the Neoadjuvant Treatment Period
- Percentage of Participants With Drop in Left Ventricular Ejection Fraction (LVEF) of at Least 10 Percentage Points From Baseline and to Below 50% During the Neoadjuvant Treatment Period
- Percentage of Participants With NYHA Class III and IV Heart Failure During the Adjuvant Treatment Period at Primary Completion Date (03 March 2016)
- (and 9 more...)
|
401 |
All |
18 Years and older (Adult, Older Adult) |
NCT02132949 |
WO29217 |
|
July 14, 2014 |
March 3, 2016 |
August 18, 2020 |
May 7, 2014 |
November 1, 2018 |
April 13, 2017 |
- University of South Alabama; Mitchell Cancer Institute
Mobile, Alabama, United States - Yuma Regional Medical Center
Yuma, Arizona, United States - Marin Specialty Care
Greenbrae, California, United States - (and 91 more...)
|
|
| 97 |
NCT00096343 |
Completed |
Paclitaxel and Carboplatin in Treating Women Who Are Undergoing Surgery for Newly Diagnosed, Locally Advanced Breast Cancer |
|
- Drug: carboplatin
- Drug: paclitaxel
|
Interventional
|
Phase 2 |
- University of Alabama at Birmingham
- National Cancer Institute (NCI)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine the clinical and pathological response in women with newly diagnosed, locally advanced operable breast cancer treated with neoadjuvant chemotherapy comprising paclitaxel and carboplatin
- Evaluate specific biomarkers for prognostic value and as markers for response/resistance in patients treated with this regimen
- Determine the tolerability and toxicity of this regimen in these patients.
|
31 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00096343 |
CDR0000377728
UAB-0137 |
|
October 2002 |
March 2005 |
March 2005 |
November 9, 2004 |
December 4, 2013 |
|
- University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
|
|
| 98 |
NCT00576901 |
Terminated
Has Results |
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer. |
|
- Drug: bevacizumab [Avastin]
- Drug: Docetaxel
- Drug: Xeloda
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Participants Achieving Pathological Complete Response (pCR)
- Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
- Progression-Free Survival
- (and 2 more...)
|
23 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00576901 |
ML20561 |
|
November 2007 |
June 2009 |
June 2009 |
December 19, 2007 |
August 11, 2014 |
August 11, 2014 |
|
|
| 99 |
NCT02682693 |
Recruiting |
Denosumab as an add-on Neoadjuvant Treatment (GeparX) |
- Breast Cancer Female NOS
- Tubular Breast Cancer Stage II
- Mucinous Breast Cancer Stage II
- (and 4 more...)
|
- Drug: Denosumab
- Drug: nab-Paclitaxel
- Drug: Epirubicin
- (and 4 more...)
|
Interventional
|
Phase 2 |
- German Breast Group
- Amgen
- Celgene Corporation
- German Breast Group
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pcR rates of neoadjuvant treatment with or without denosumab in addition to nab-paclitaxel and EC.
- pcR (ypT0 ypN0) rates of nab-Paclitaxel weekly for 12 weeks or 2 of 3 weeks for 12 weeks
- To test for interaction of denosumab treatment with RANK expression.
- To assess the pCR rates per arm for both randomizations separately for TNBC and HR-/HER2+ tumors.
|
778 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02682693 |
GBG 88 |
GeparX |
February 13, 2017 |
December 2018 |
December 2018 |
February 15, 2016 |
July 13, 2017 |
|
- Kliniken Essen-Mitte
Essen, NRW, Germany
|
|
| 100 |
NCT01730833 |
Active, not recruiting |
Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer |
- HER2-positive Breast Cancer
- Recurrent Breast Cancer
- Stage IIA Breast Cancer
- (and 7 more...)
|
- Biological: pertuzumab
- Biological: trastuzumab
- Drug: paclitaxel albumin-stabilized nanoparticle formulation
- Other: laboratory biomarker analysis
|
Interventional
|
Phase 2 |
- City of Hope Medical Center
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival
- PFS (MBC patients)
- PFS (LABC patients)
- (and 6 more...)
|
65 |
Female |
19 Years and older (Adult, Older Adult) |
NCT01730833 |
12147
NCI-2012-02371
R01CA166020
AACR Grant 12-60-26-WANG |
|
July 17, 2013 |
August 2019 |
August 2019 |
November 21, 2012 |
November 6, 2018 |
|
- City of Hope Medical Center
Duarte, California, United States - City of Hope Antelope Valley
Lancaster, California, United States - City of Hope- South Pasadena Cancer Center
South Pasadena, California, United States
|
|
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