| 1 |
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
|
|
| 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 |
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
|
|
| 4 |
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...)
|
|
| 5 |
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...)
|
|
| 6 |
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 |
|
|
|
| 7 |
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
|
|
| 8 |
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
|
|
| 9 |
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
|
|
| 10 |
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
|
|
| 11 |
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
|
|
| 12 |
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
|
|
| 13 |
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
|
|
| 14 |
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
|
|
| 15 |
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...)
|
|
| 16 |
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
|
|
| 17 |
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
|
|
| 18 |
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...)
|
|
| 19 |
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
|
|
| 20 |
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...)
|
|
| 21 |
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...)
|
|
| 22 |
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
|
|
| 23 |
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
|
|
| 24 |
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...)
|
|
| 25 |
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
|
|
| 26 |
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
|
|
| 27 |
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
|
|
| 28 |
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
|
|
| 29 |
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...)
|
|
| 30 |
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
|
|
| 31 |
NCT00072319 |
Completed |
Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer |
|
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: epirubicin hydrochloride
- (and 3 more...)
|
Interventional
|
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- National Cancer Institute (NCI)
- Pharmacia
- (and 2 more...)
|
Other / NIH / Industry |
- Primary Purpose: Treatment
|
|
|
Female |
18 Years and older (Adult, Older Adult) |
NCT00072319 |
03-092
P30CA008748
MSKCC-03092 |
|
August 2003 |
November 2006 |
November 2006 |
November 6, 2003 |
March 4, 2013 |
|
- Memorial Sloan-Kettering Cancer Center
New York, New York, United States
|
|
| 32 |
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
|
|
| 33 |
NCT00005798 |
Completed |
Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer |
|
- Drug: Carboplatin
- Drug: Cyclophosphamide
- Drug: Thiotepa
|
Interventional
|
Phase 2 |
- H. Lee Moffitt Cancer Center and Research Institute
- National Cancer Institute (NCI)
- H. Lee Moffitt Cancer Center and Research Institute
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- relapse-free survival
- Rate of Grade III/IV toxicities
|
209 |
Female |
15 Years to 64 Years (Child, Adult) |
NCT00005798 |
MCC-11072
IRB-3898
NCI-G00-1760 |
CTC |
July 1995 |
August 2001 |
July 2007 |
April 2, 2004 |
October 26, 2012 |
|
- Halifax Medical Center
Daytona Beach, Florida, United States - Florida Cancer Specialists
Fort Myers, Florida, United States - H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
|
|
| 34 |
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
|
|
| 35 |
NCT00464646 |
Completed
Has Results |
Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer |
|
- Drug: Epirubicin
- Drug: Cyclophosphamide
- Drug: Docetaxel
- (and 2 more...)
|
Interventional
|
Phase 2 |
- NSABP Foundation Inc
- Genentech, Inc.
- International Drug Development Institute
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)
- Cardiac Event Rate as Determined by LVEF Assessment
- pCR in the Breast (Cohort A)
- (and 5 more...)
|
105 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00464646 |
NSABP FB-5 |
|
May 2007 |
December 2009 |
May 2014 |
April 23, 2007 |
July 25, 2014 |
September 26, 2012 |
- Clearview Cancer Institute- Huntsville
Huntsville, Alabama, United States - Kaiser Permanente-San Diego
San Diego, California, United States - Kaiser Permanente-Vallejo
Vallejo, California, United States - (and 33 more...)
|
|
| 36 |
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...)
|
|
| 37 |
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
|
|
| 38 |
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
|
|
| 39 |
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...)
|
|
| 40 |
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
|
|
| 41 |
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
|
|
| 42 |
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
|
|
| 43 |
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...)
|
|
| 44 |
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
|
|
| 45 |
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...)
|
|
| 46 |
NCT00288002 |
Completed |
Combination Chemotherapy With or Without Capecitabine and/or Trastuzumab Before Surgery in Treating Women With Stage I, Stage II, or Stage III Breast Cancer |
|
- Biological: trastuzumab
- Drug: capecitabine
- Drug: cyclophosphamide
- (and 5 more...)
|
Interventional
|
Phase 3 |
- German Breast Group
- National Cancer Institute (NCI)
|
Other |
- Allocation: Randomized
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathologic complete response
|
1500 |
Female |
18 Years and older (Adult, Older Adult) |
NCT00288002 |
CDR0000455125
GBG-GEPARQUATTRO
GBG-40
EU-205101
AVENTIS-GBG-GEPARQUATTRO
ROCHE-AVENTIS-GBG-GEPARQUATTRO
EUDRACT-2005-001546-17 |
|
January 2005 |
|
|
February 7, 2006 |
August 26, 2013 |
|
- Universitaetsfrauenklinik Frankfurt
Neu-Isenburg, Germany
|
|
| 47 |
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
|
|
| 48 |
NCT01093235 |
Unknown † |
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer |
- Breast Cancer
- Cardiac Toxicity
- Perioperative/Postoperative Complications
|
- Biological: bevacizumab
- Drug: cyclophosphamide
- Drug: docetaxel
- (and 6 more...)
|
Interventional
|
Phase 3 |
- Cambridge University Hospitals NHS Foundation Trust
- National Cancer Institute (NCI)
|
Other |
- Allocation: Randomized
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Complete pathological response rates (tumor and lymph nodes)
- Disease-free survival
- Overall survival
- (and 5 more...)
|
800 |
All |
18 Years and older (Adult, Older Adult) |
NCT01093235 |
CDR0000668530
CRCA-CCTC-WCTU-ARTemis
ISRCTN68502941
EUDRACT-2008-002322-11
EU-21017
MREC-08/H1102/104 |
|
April 2009 |
April 2012 |
|
March 25, 2010 |
March 25, 2010 |
|
- Addenbrooke's Hospital
Cambridge, England, United Kingdom
|
|
| 49 |
NCT00499083 |
Completed
Has Results |
Paclitaxel, Cyclophosphamide, and Doxorubicin Followed by Autologous Dendritic Cells and Surgery With or Without Radiation Therapy and/or Hormone Therapy in Treating Women With Stage II or Stage III Breast Cancer |
|
- Biological: therapeutic autologous dendritic cells
- Drug: aromatase inhibition therapy
- Drug: cyclophosphamide
- (and 14 more...)
|
Interventional
|
Phase 2 |
- University of Nebraska
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients With Pathological Complete Response
- Inflammatory Cell Infiltration
- Antibody-dependent Cell-mediated Cytotoxicity
- Influence of Tumor COX-2 and VEGF Expression on Dendritic Cell-mediated Tumor-specific Immunity
|
17 |
Female |
19 Years to 120 Years (Adult, Older Adult) |
NCT00499083 |
072-06
P30CA036727
UNMC-07206 |
|
May 2006 |
July 2009 |
January 2010 |
July 11, 2007 |
July 2, 2018 |
July 2, 2018 |
- H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
|
|
| 50 |
NCT01067989 |
Terminated |
Low-Dose/Metronomic(LDM)Chemotherapy for Metastatic Breast Cancer |
- Chemotherapy
- Breast Cancer, Metastatic
|
- Drug: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate)
|
Interventional
|
Phase 2 |
- HaEmek Medical Center, Israel
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)
- Plasma Levels of angiogenic growth factors
|
22 |
Female |
18 Years to 80 Years (Adult, Older Adult) |
NCT01067989 |
0078-09-EMC |
|
March 2010 |
April 2014 |
April 2014 |
February 12, 2010 |
July 8, 2015 |
|
- Oncology unit
Afula, Israel
|
|
| 51 |
NCT01964391 |
Active, not recruiting |
A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer |
|
- Drug: Trastuzumab
- Drug: Doxorubicin
- Drug: Cyclophosphamide
- (and 4 more...)
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Participant Satisfaction Questionnaire Score
- Percentage of Participants with Adverse Events (AEs)
- Healthcare Professional Experience and Satisfaction Questionnaire Score
- (and 6 more...)
|
174 |
All |
18 Years and older (Adult, Older Adult) |
NCT01964391 |
ML28851 |
|
February 21, 2014 |
December 22, 2016 |
December 22, 2018 |
October 17, 2013 |
September 10, 2018 |
|
- Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale
Algiers, Algeria - Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale
Algiers, Algeria - CHU Annaba; Service d'Oncologie Médicale
Annaba, Algeria - (and 20 more...)
|
|
| 52 |
NCT03144947 |
Recruiting |
Biomarker Study of Immune-mediated Mechanism of Action of Neoadjuvant Trastuzumab in Patients With HER2-positive Breast Cancer |
|
- Biological: Trastuzumab IV
- Biological: Trastuzumab SC
- Biological: Pertuzumab
- Drug: Docetaxel
|
Interventional
|
Phase 2 |
- Gruppo Oncologico Italiano di Ricerca Clinica
- University Hospital of Parma: Department of Biomedical, Biotechnological and Translational Sciences, Pathological Anatomy and Histology Unit
- University Hospital of Parma:Laboratory of Viral Immunopathology, Unit of Infectious Diseases and Hepatology
- (and 5 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Tumor Infiltrating lymphocites (TIL) rate on residual disease after either IV trastuzumab or SC trastuzumab (see related paragraph)
- Associations between biomarkers (TIL, Tumor specific lymphocyte cell activity (TLA), and Fc-gamma-R polymorphisms) and between each biomarker with clinical outcome variables.
- Frequency of toxicity Events: frequency of moderate and severe toxicity events and drop-out rate due to theraphy related toxicity (NCICommon Toxicity Criteria v 4.0)
- (and 3 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03144947 |
GOIRC-01-2016 |
IMMUN-HER |
November 29, 2016 |
December 2018 |
January 2019 |
May 9, 2017 |
May 9, 2017 |
|
- UO di Oncologia Ematologia, Azienda Ospedaliero Universitaria di Ferrara
Cona, Ferrara, Italy - UOC Oncologia Medica, Azienda ULSS21 di Legnago
Legnago, Verona, Italy - Oncologia Medica, Ospedale Sacro Cuore - Don Calabria - Negrar (VR)
Negrar, Verona, Italy - (and 18 more...)
|
|
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