| 1 |
NCT03244358 |
Recruiting |
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer |
- Triple Negative Breast Cancer
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Overall Survival
|
30 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03244358 |
SYSUCC-010 |
|
March 1, 2017 |
July 1, 2018 |
July 1, 2018 |
August 9, 2017 |
January 17, 2018 |
|
- Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
|
| 2 |
NCT03154749 |
Recruiting |
TC (Docetaxel/Carboplatin) Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer |
- Triple-Negative Breast Cancer
|
- Drug: TC (docetaxel/carboplatin) versus EC followed by T (epirubicin/cyclophosphamide followed by docetaxe)
|
Interventional |
Phase 2 |
- Guangdong General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
74 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03154749 |
20170512 |
|
September 1, 2016 |
September 1, 2018 |
September 1, 2019 |
May 16, 2017 |
May 16, 2017 |
|
- Guangdong General Hospital
Guangzhou, Guangdong, China
|
| 3 |
NCT01216111 |
Available |
Comparison Study of Adjuvant Chemotherapy for Chinese Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Paclitaxel Cisplatin
|
Expanded Access |
|
- Fudan University
- Chinese Anti-Cancer Association
|
Other |
|
|
|
Female |
18 Years to 65 Years (Adult) |
NCT01216111 |
Fudan TNBC Adjuvant CT |
|
|
|
|
October 7, 2010 |
October 7, 2010 |
|
|
| 4 |
NCT02977468 |
Recruiting |
Effects of MK-3475 (Pembrolizumab) on the Breast Tumor Microenvironment in Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Merck 3475 Pembrolizumab
- Radiation: Intraoperative radiation therapy (IORT)
|
Interventional |
Phase 1 |
- Eileen Connolly
- Merck Sharp & Dohme Corp.
- Columbia University
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects with signifcant mean percent change in TILs
|
15 |
Female |
21 Years to 80 Years (Adult, Senior) |
NCT02977468 |
AAAQ7863 |
Pembro/IORT |
October 25, 2017 |
December 2019 |
December 2020 |
November 30, 2016 |
January 5, 2018 |
|
- Columbia University Medical Center
New York, New York, United States
|
| 5 |
NCT02247037 |
Recruiting |
Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
|
Observational |
|
- Icahn School of Medicine at Mount Sinai
- Champions Oncology
|
Other / Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Patient Tumor Response
- Model Tumor Response
|
140 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02247037 |
GCO 14-0686 |
|
July 2014 |
June 2019 |
June 2019 |
September 23, 2014 |
July 21, 2017 |
|
- Mount Sinai Beth Israel
New York, New York, United States - Mount Sinai Roosevelt
New York, New York, United States - Mount Sinai St. Luke's
New York, New York, United States - Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai
New York, New York, United States
|
| 6 |
NCT03243838 |
Not yet recruiting |
Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer |
- Triple-Negative Breast Cancer
|
|
Interventional |
Phase 1
Phase 2 |
- Guangdong General Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
40 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03243838 |
20170328 |
LANCET |
April 2, 2018 |
December 30, 2019 |
December 30, 2019 |
August 9, 2017 |
February 6, 2018 |
|
- Guangdong general hospital
Guangzhou, Guangdong, China
|
| 7 |
NCT03358017 |
Not yet recruiting |
Neoadjuvant Zoledronate and Atorvastatin in Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Zoledronate
- Drug: Atorvastatin 80mg
- Drug: Standard neoadjuvant cht
|
Interventional |
Phase 2 |
- Mario Negri Institute for Pharmacological Research
- Associazione Italiana per la Ricerca sul Cancro
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proof of concept primary activity endpoint - Efficacy endpoint
- The proportion of responded patients
- In relation to high/low p53 levels, relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis. Efficacy endpoint
- (and 8 more...)
|
154 |
Female |
18 Years and older (Adult, Senior) |
NCT03358017 |
IRFMN-BRC-7103
2016-005112-17 |
YAPPETIZER |
December 15, 2017 |
July 25, 2020 |
July 25, 2020 |
November 30, 2017 |
November 30, 2017 |
|
- Azienda Socio Sanitaria Territoriale ASST Lariana - Presidio Ospedaliero Ospedale S. Anna
San Fermo della Battaglia, Como, Italy - Azienda Socio Sanitaria Territoriale - ASST Papa Giovanni XXIII
Bergamo, Italy - Azienda Ospedaliero Universitaria di Bologna Policlinico S.Orsola - Malpighi
Bologna, Italy - (and 7 more...)
|
| 8 |
NCT02993094 |
Recruiting |
Ixazomib (MLN9708) in Combination With Carboplatin in Pretreated Women With Advanced Triple Negative Breast Cancer |
- Triple-Negative Breast Cancer
|
- Drug: Ixazomib
- Drug: Carboplatin
|
Interventional |
Phase 1
Phase 2 |
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Takeda
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD)
- Safety profile based on adverse events evaluation
- Overall response rate
- (and 3 more...)
|
53 |
Female |
18 Years and older (Adult, Senior) |
NCT02993094 |
AGMT_MBC-10 (X16087)
2016-001421-13 |
|
November 2016 |
September 2019 |
September 2019 |
December 15, 2016 |
November 24, 2017 |
|
- Klinikum Kreuzschwestern Wels GmbH
Wels, Oberösterreich, Austria - Universitätsklinik für Innere Medizin Graz
Graz, Steiermark, Austria - Universitätsklinik für Frauenheilkunde Innsbruck
Innsbruck, Tirol, Austria - (and 6 more...)
|
| 9 |
NCT03077776 |
Recruiting |
Tracking Triple-negative Breast Cancer Evolution Through Therapy |
- Triple-Negative Breast Neoplasm
|
- Procedure: Biopsy
- Procedure: Biopsy (optional)
- Procedure: Biopsy (metastatic)
|
Interventional |
Not Applicable |
- UNICANCER
- National Cancer Institute, France
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Rate of pathological complete response (pCR)
- Invasive disease-free survival
- Overall survival
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT03077776 |
UC0105/1614
ID RCB: 2016-A01177-44 |
TRACERX-TNBC |
April 14, 2017 |
January 2025 |
July 2025 |
March 13, 2017 |
November 1, 2017 |
|
- Centre Leon Bérard
Lyon, France - Institut Paoli Calmettes
Marseille, France - Institut de Cancerologie de l'Ouest
Nantes-Saint Herblain, France - (and 3 more...)
|
| 10 |
NCT03499899 |
Not yet recruiting
New |
A Study of Efficacy and Safety of LAG525 in Combination With Spartalizumab, or With Spartalizumab and Carboplatin, or With Carboplatin, in Patients With Advanced Triple-negative Breast Cancer |
- Triple-negative Breast Cancer
|
- Drug: LAG525
- Drug: spartalizumab
- Drug: carboplatin
|
Interventional |
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) per RECIST v1.1 per investigators' assessment
- Duration of response (DOR)
- Overall Survival (OS)
- (and 8 more...)
|
126 |
All |
18 Years and older (Adult, Senior) |
NCT03499899 |
CLAG525B2101 |
|
June 20, 2018 |
September 30, 2019 |
October 12, 2020 |
April 17, 2018 |
April 17, 2018 |
|
|
| 11 |
NCT02266420 |
Recruiting |
Comparison of Biological Features Between pN0 Triple Negative Breast Tumours With Size < or = 10 mm (pT1a/b) Versus pT1c T2 < or = 30 mm |
- Triple Negative Breast Cancers Without Lymph-node Involvement and < or = 30 mm
|
- Procedure: Blood samples of 10 mL
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Biomarker signature for pT1a/b pN0 triple-negative breast cancers versus pN0 triple-negative breast cancers with size > or = 11 mm and < or = 30 mm.
- Disease free survival.
- Metastasis Free Survival.
- (and 2 more...)
|
200 |
Female |
18 Years and older (Adult, Senior) |
NCT02266420 |
14 SEIN 09 |
COCABIO000 |
October 23, 2014 |
October 2021 |
October 2022 |
October 17, 2014 |
October 25, 2017 |
|
- Institut de Cancerologie de L'Ouest - Site Paul Papin
Angers, France - Centre Francois Baclesse
Caen, France - Centre Jean Perrin
Clermont-Ferrand, France - (and 10 more...)
|
| 12 |
NCT02161679 |
Not yet recruiting |
Phase II Study of IMMU-132 Alone or in Combination With Carboplatin in Patients With Triple-Negative Breast Cancer |
- Triple-negative Breast Cancer
|
- Drug: IMMU-132 infusion is administered to participants in one arm for the study
- Drug: IMMU-132 plus Carboplatin infusion
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression Free Survival
|
80 |
All |
18 Years to 90 Years (Adult, Senior) |
NCT02161679 |
IMMU-132-02 |
|
August 2016 |
August 2018 |
|
June 12, 2014 |
October 12, 2015 |
|
|
| 13 |
NCT03175666 |
Not yet recruiting |
NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy |
- Triple Negative Breast Cancer
|
- Biological: avelumab
- Biological: bevacizumab
- Drug: capecitabine
- (and 15 more...)
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of treatment-emergent adverse events (AEs) and serious AEs (SAEs), graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03.
- Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- ORR by Immune-related response criteria (irRC )
- (and 9 more...)
|
79 |
All |
18 Years and older (Adult, Senior) |
NCT03175666 |
QUILT-3.049 |
|
December 2017 |
January 2019 |
March 2019 |
June 5, 2017 |
October 30, 2017 |
|
|
| 14 |
NCT03457779 |
Recruiting |
Pilot Study To Investigate Targetable Metabolic Pathways Sustaining Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Dietary Supplement: Glucose
|
Interventional |
Not Applicable |
- Baylor Research Institute
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Amount of glucose, amino acid, and lipid metabolites in TNBC.
- Correlation of signaling pathways in TNBC with response and metabolites.
|
16 |
Female |
18 Years and older (Adult, Senior) |
NCT03457779 |
017-396 |
|
February 8, 2018 |
August 8, 2019 |
August 8, 2020 |
March 8, 2018 |
March 8, 2018 |
|
- Baylor University Medical Center
Dallas, Texas, United States
|
| 15 |
NCT03167619 |
Not yet recruiting |
Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) |
- Triple Negative Breast Cancer
|
- Drug: Olaparib Oral Product
- Drug: Olaparib Oral Product in combination with Durvalumab
|
Interventional |
Phase 2 |
- Kimberly Blackwell
- AstraZeneca
- Duke University
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy as assessed by PFS
- Overall Survival Olaparib alone
- Overall Survival olaparib in combination with Durvalumab
- (and 4 more...)
|
60 |
Female |
21 Years and older (Adult, Senior) |
NCT03167619 |
Pro00080769 |
DORA |
May 2018 |
October 2019 |
April 2020 |
May 30, 2017 |
January 4, 2018 |
|
|
| 16 |
NCT03387085 |
Not yet recruiting |
QUILT-3.067 NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. |
- Triple Negative Breast Cancer
|
- Drug: Aldoxorubicin HCl
- Biological: ALT-803
- Biological: ETBX-011
- (and 16 more...)
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), graded using the NCI CTCAE Version 4.03.
- Objective response rate by RECIST
- Objective response rate by irRC
- (and 8 more...)
|
79 |
All |
18 Years and older (Adult, Senior) |
NCT03387085 |
QUILT-3.067 |
|
January 2018 |
January 2019 |
January 2020 |
December 29, 2017 |
January 8, 2018 |
|
- Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States
|
| 17 |
NCT03444025 |
Not yet recruiting |
Neoadjuvant Goserelin for Triple Negative Breast Cancer |
- Breast Cancer Triple Negative
|
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pathologic complete response rate
- LHRH-positive and/or AR-positive Rate
- Relapse-free Survival
- (and 3 more...)
|
180 |
Female |
18 Years to 60 Years (Adult) |
NCT03444025 |
B2017-11 |
NeoGONT |
March 2018 |
March 2021 |
March 2023 |
February 23, 2018 |
February 23, 2018 |
|
|
| 18 |
NCT03251313 |
Not yet recruiting |
PD-1(Programmed Death-1) Antibody +GP as First Line Treatment for Triple Negative Breast Cancer(TNBC) Patients |
- Triple Negative Breast Cancer
|
- Combination Product: JS001 120mg+GP
- Combination Product: JS001 240mg+GP
- Combination Product: JS001 480mg+GP
- Combination Product: GP followed by JS001
|
Interventional |
Phase 1 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum Tolerated Dose (MTD) of JS001 when combined with GP
- Peak Plasma Concentration (Cmax)
- Area under the plasma concentration versus time curve (AUC)
- (and 10 more...)
|
33 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03251313 |
Fudan-P1-201701 |
|
November 2017 |
December 2019 |
December 2020 |
August 16, 2017 |
October 27, 2017 |
|
|
| 19 |
NCT03473691 |
Not yet recruiting
New |
Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Glembatumumab Vedotin
|
Interventional |
Early Phase 1 |
- University of Virginia
- Celldex Therapeutics
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Adverse Events (AEs)
- Proportion of patients who complete the 4 cycles of GV within 15 weeks of the first dose of GV (without dose limiting adverse events).
- Number of discontinuations due to AEs
- (and 3 more...)
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT03473691 |
TBDBreast50 |
Breast50 |
March 31, 2018 |
March 31, 2021 |
March 31, 2023 |
March 22, 2018 |
March 22, 2018 |
|
|
| 20 |
NCT03193853 |
Recruiting |
TAK-228 and TAK-117 Followed by Cisplatin and Nab Paclitaxel for Metastatic Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Tak-228 & Tak-117
- Drug: Cisplatin & Nab Paclitaxel
|
Interventional |
Phase 2 |
- Baylor Research Institute
- Takeda
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy (objective response rate)
- Efficacy (duration of response)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
|
20 |
Female |
18 Years and older (Adult, Senior) |
NCT03193853 |
017- 113 PIKTOR
Baylor 017-113 |
|
July 18, 2017 |
June 9, 2021 |
June 9, 2022 |
June 21, 2017 |
February 12, 2018 |
|
- Baylor University Medical Center
Dallas, Texas, United States
|
| 21 |
NCT02768701 |
Recruiting |
Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Pembrolizumab
- Drug: Cyclophosphamide
|
Interventional |
Phase 2 |
- UNC Lineberger Comprehensive Cancer Center
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Progression Free Survival (PFS)
|
36 |
All |
18 Years and older (Adult, Senior) |
NCT02768701 |
LCCC 1525 |
|
October 2016 |
December 2018 |
December 2022 |
May 11, 2016 |
October 18, 2017 |
|
- George Washington University-Medical Faculty Associates
Washington, D.C., District of Columbia, United States - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States - Cone Health Cancer Center
Greensboro, North Carolina, United States - (and 2 more...)
|
| 22 |
NCT02984683 |
Recruiting |
Study Evaluating Efficacy and Safety of SAR566658 Treatment in Patients With CA6 Positive Metastatic Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: SAR566658 (ACT14884)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response rate (ORR)
- Disease control rate
- Duration of response - time
- (and 4 more...)
|
62 |
All |
18 Years and older (Adult, Senior) |
NCT02984683 |
ACT14884
2016‐001962‐27
U1111-1182-7044 |
|
March 14, 2017 |
December 20, 2019 |
December 20, 2019 |
December 7, 2016 |
April 12, 2018 |
|
- Investigational Site Number 8400003
Dallas, Texas, United States - Investigational Site Number 8400002
El Paso, Texas, United States - Investigational Site Number 0560002
Bruxelles, Belgium - (and 17 more...)
|
| 23 |
NCT03424005 |
Recruiting |
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC) |
- Triple Negative Breast Cancer
|
- Drug: Capecitabine
- Drug: Atezolizumab
- Drug: Ipatasertib
- (and 4 more...)
|
Interventional |
Phase 1
Phase 2 |
- Hoffmann-La Roche
- Seattle Genetics, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate (ORR)
- Progression Free Survival (PFS)
- Disease Control Rate (DCR)
- (and 9 more...)
|
260 |
All |
18 Years and older (Adult, Senior) |
NCT03424005 |
CO40115
2017-002038-21 |
Morpheus-TNBC |
March 15, 2018 |
August 1, 2021 |
August 1, 2021 |
February 6, 2018 |
March 2, 2018 |
|
- University of California San Diego Medical Center; Moores Cancer Center
La Jolla, California, United States - Hackensack Univ Medical Center; John Theurer Cancer Ctr
Hackensack, New Jersey, United States - Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States - (and 17 more...)
|
| 24 |
NCT03281954 |
Recruiting |
Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo |
- Triple Negative Breast Cancer
|
- Drug: Placebo
- Drug: Atezolizumab
|
Interventional |
Phase 3 |
- NSABP Foundation Inc
- Genentech, Inc.
- Hoffmann-La Roche
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
- Event-free survival (EFS)
- Pathologic complete response in the breast (ypT0/Tis)
- (and 10 more...)
|
1520 |
All |
18 Years and older (Adult, Senior) |
NCT03281954 |
NSABP B-59/GBG 96-GeparDouze
2017-002771-25
MO39875 |
|
December 19, 2017 |
December 31, 2023 |
June 30, 2024 |
September 13, 2017 |
March 30, 2018 |
|
- UF Health Cancer Center at Orlando Health
Orlando, Florida, United States - John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States - Medstar Union Memorial Hospital
Baltimore, Maryland, United States - (and 18 more...)
|
| 25 |
NCT03498716 |
Not yet recruiting
New |
A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Atezolizumab
- Drug: Paclitaxel
- Drug: Dose-dense Doxorubicin or dose-dense Epirubicin
- Drug: Cyclophosphamide
|
Interventional |
Phase 3 |
- Hoffmann-La Roche
- Breast International Group
- Alliance Foundation Trials (AFT)
- (and 2 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Invasive Disease-Free Survival (iDFS)
- Overall Survival (OS)
- Disease-Free Survival (DFS)
- (and 10 more...)
|
2300 |
All |
18 Years and older (Adult, Senior) |
NCT03498716 |
WO39391
2016-003695-47
BIG 16-05
AFT-27 |
IMpassion030 |
April 25, 2018 |
January 15, 2022 |
December 29, 2024 |
April 17, 2018 |
April 17, 2018 |
|
- John Muir Health Clinical Research Center
Concord, California, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - Baptist - MD Anderson Cancer Center
Jacksonville, Florida, United States - (and 260 more...)
|
| 26 |
NCT03371017 |
Recruiting |
A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer |
- Triple Negative Breast Neoplasms
|
- Drug: Atezolizumab
- Drug: Placebo
- Drug: Gemcitabine
- (and 2 more...)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Overall survival (OS)
- Proportion of patients alive 12 months
- Proportion of patients alive 18 months
- (and 4 more...)
|
350 |
All |
18 Years and older (Adult, Senior) |
NCT03371017 |
MO39193
2016-005119-42 |
IMpassion132 |
January 31, 2018 |
July 31, 2019 |
January 31, 2021 |
December 13, 2017 |
December 27, 2017 |
|
- Florida Cancer Specialists & Research Institute
Saint Petersburg, Florida, United States - Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States - The Valley Hospital
Paramus, New Jersey, United States - (and 78 more...)
|
| 27 |
NCT03168880 |
Recruiting |
A Randomized Controlled Trial of Neoadjuvant Weekly Paclitaxel Versus Weekly Paclitaxel Plus Weekly Carboplatin In Women With Large Operable or Locally Advanced, Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Paclitaxel + Carboplatin
- Drug: Paclitaxel only
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
720 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03168880 |
CTRI/2012/07/002802 |
TNBC |
April 2010 |
November 30, 2019 |
November 30, 2024 |
May 30, 2017 |
May 30, 2017 |
|
- Tata memorial Centre
Mumbai, Maharashtra, India
|
| 28 |
NCT03358004 |
Recruiting |
the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After First Line Treatment |
- Triple Negative Breast Cancer
|
- Drug: Vinorelbine Tartrate
- Drug: Capecitabine 500 MG
|
Interventional |
Phase 2 |
- Mario Negri Institute for Pharmacological Research
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- PFS-12 weeks
- OS
- PFS
- Incidence of Adverse Events
|
180 |
Female |
18 Years and older (Adult, Senior) |
NCT03358004 |
IRFMN-BRC-6992 |
VICTOR3 |
October 30, 2017 |
September 15, 2019 |
September 15, 2020 |
November 30, 2017 |
November 30, 2017 |
|
- AOU Ospedali riuniti di Ancona
Torrette, Ancona, Italy - ASST Monza
Monza, MB, Italy - Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy - (and 28 more...)
|
| 29 |
NCT03197935 |
Recruiting |
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer |
- Triple-negative Breast Cancer
|
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
- Drug: Placebo
- Drug: Nab-paclitaxel
- (and 4 more...)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percentage of Participants with Pathologic Complete Response (pCR) Using American Joint Committee on Cancer (AJCC) Staging System
- Percentage of Participants with pCR in Subpopulation with PD-L1-Selected Tumor Status (tumor-infiltrating immune cell [IC] 1/2/3) Using AJCC Staging System
- Event-Free Survival (EFS) Using AJCC Staging System
- (and 5 more...)
|
204 |
All |
18 Years and older (Adult, Senior) |
NCT03197935 |
WO39392
2016-004734-22 |
IMpassion031 |
July 25, 2017 |
March 19, 2019 |
September 26, 2021 |
June 23, 2017 |
April 17, 2018 |
|
- Stanford University Medical Center
Palo Alto, California, United States - Norwalk Hospital
Norwalk, Connecticut, United States - SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States - (and 74 more...)
|
| 30 |
NCT02413320 |
Recruiting |
Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer |
- Triple-negative Breast Cancer
|
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: Doxorubicin
- (and 2 more...)
|
Interventional |
Phase 2 |
- Priyanka Sharma
- University of Kansas Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological complete response rates
- Minimal residual disease rates
|
100 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT02413320 |
2015-IIT-Neoadjuvant-BRST-TNBC |
NeoSTOP |
July 2015 |
July 2018 |
December 2018 |
April 9, 2015 |
October 30, 2017 |
|
- University of Kansas Cancer Center - CRC
Fairway, Kansas, United States - Hays Medical Center
Hays, Kansas, United States - University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States - (and 6 more...)
|
| 31 |
NCT03125902 |
Recruiting |
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) |
- Triple-Negative Breast Cancer
|
- Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
- Drug: Atezolizumab Placebo
- Drug: Paclitaxel
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Percentage of Participants Who are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1
- Overall Survival (OS)
- (and 12 more...)
|
540 |
All |
18 Years and older (Adult, Senior) |
NCT03125902 |
MO39196
2016-004024-29 |
IMpassion131 |
August 25, 2017 |
February 28, 2019 |
June 30, 2021 |
April 24, 2017 |
April 10, 2018 |
|
- Stanford Cancer Center
Stanford, California, United States - Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, United States - Northwest Georgia Oncology Centers PC - Marietta
Marietta, Georgia, United States - (and 161 more...)
|
| 32 |
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: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological Complete Response (pCR) rate
|
85 |
Female |
18 Years and older (Adult, Senior) |
NCT02124902 |
201404107 |
|
July 7, 2014 |
September 30, 2018 |
September 30, 2018 |
April 28, 2014 |
April 12, 2018 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
| 33 |
NCT03036488 |
Recruiting |
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522) |
- Triple Negative Breast Neoplasms
|
- Biological: Pembrolizumab
- Drug: Carboplatin
- Drug: Paclitaxel
- (and 4 more...)
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
- Event-free Survival (EFS) as assessed by Investigator
- pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery
- (and 7 more...)
|
855 |
All |
18 Years and older (Adult, Senior) |
NCT03036488 |
3475-522
2016-004740-11
173567 |
|
March 7, 2017 |
November 1, 2018 |
March 14, 2025 |
January 30, 2017 |
April 20, 2018 |
|
- Scottsdale Healthcare Hospitals D/B/A HonorHealth ( Site 0089)
Scottsdale, Arizona, United States - Arizona Oncology Associates PC- HOPE ( Site 8001)
Tucson, Arizona, United States - Cedars Sinai Medical Center ( Site 0091)
Los Angeles, California, United States - (and 190 more...)
|
| 34 |
NCT03121352 |
Recruiting |
Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer |
- Metastatic Triple Negative Breast Cancer
|
- Drug: Carboplatin
- Drug: Nab-paclitaxel
- Drug: Pembrolizumab
|
Interventional |
Phase 2 |
- Case Comprehensive Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Determine overall response rate (ORR) in patients treated with CNP
- Determine progression-free survival (PFS) in patients treated with CNP
- Determine disease control rate (DCR) in patients treated with CNP
- Determine duration of response in patients treated with CNP
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT03121352 |
CASE6115 |
|
May 19, 2017 |
March 2019 |
March 2019 |
April 20, 2017 |
June 8, 2017 |
|
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States - Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
|
| 35 |
NCT03002103 |
Recruiting |
A Trial Evaluating the Efficacy and Safety of EndoTAG®-1 in Combination With Paclitaxel and Gemcitabine Compared With Paclitaxel and Gemcitabine as First-line Therapy in Patients With Visceral Metastatic Triple-negative Breast Cancer |
- Triple-Negative Breast Cancer
|
- Drug: EndoTAG-1
- Drug: Paclitaxel
- Drug: Gemcitabine Hydrochloride
|
Interventional |
Phase 3 |
- SynCore Biotechnology Co., Ltd.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- PFS
- Overall survival
- Clinical benefit rate
- (and 4 more...)
|
420 |
Female |
18 Years and older (Adult, Senior) |
NCT03002103 |
CT4005 |
|
November 2016 |
December 2021 |
December 2022 |
December 23, 2016 |
March 23, 2018 |
|
- Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan - MacKay Memorial Hospital, Taipei branch
Taipei, Taiwan - Chang Gung Memorial Hospital, Linkou
Taoyuan, Taiwan
|
| 36 |
NCT02926196 |
Recruiting |
Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab |
- Triple Negative Breast Neoplasms
|
|
Interventional |
Phase 3 |
- Istituto Oncologico Veneto IRCCS
- University of Padova
- Dipartimento di scienze chirurgiche, Oncologiche e Gastroenterologiche
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Disease free survival
- Disease free survival in PD-L1-positive patients
- Overall survival
- Safety profile
|
335 |
All |
18 Years and older (Adult, Senior) |
NCT02926196 |
A-BRAVE-Trial
2016-000189-45 |
A-Brave |
June 2016 |
June 2021 |
June 2023 |
October 6, 2016 |
June 20, 2017 |
|
- Istituto Tumori G.Paolo II
Bari, BA, Italy - Ospedale di Bergamo
Bergamo, BG, Italy - Policlinico Sant'Orsola Malpighi
Bologna, BO, Italy - (and 37 more...)
|
| 37 |
NCT03254654 |
Recruiting |
Vinorelbine Plus Apatinib Versus Vinorelbine in Advanced Triple-Negative Breast Cancer |
- Advanced Triple-Negative Breast Cancer
|
- Drug: Vinorelbine
- Drug: Apatinib
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- PFS
- OS
- ORR
- Safety: Number of Participants with Adverse Events
|
66 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03254654 |
Fudan BR2017-23 |
|
August 16, 2017 |
August 2019 |
August 2020 |
August 18, 2017 |
January 23, 2018 |
|
- Fudan University Cancer Hospital
Shanghai, China
|
| 38 |
NCT03145961 |
Recruiting |
A Trial Using ctDNA Blood Tests to Detect Cancer Cells After Standard Treatment to Trigger Additional Treatment in Early Stage Triple Negative Breast Cancer Patients |
- Triple Negative Breast Cancer
|
|
Interventional |
Phase 2 |
- Institute of Cancer Research, United Kingdom
- National Institute for Health Research Biomedical Research Centre at the Royal Marsden / Institute of Cancer Research UK
- Merck Sharp & Dohme Ltd
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Positive ctDNA detection by 12 months
- Positive ctDNA detection by 24 months
- Absence of detectable ctDNA or disease recurrence 12 months after commencing pembrolizumab
- (and 6 more...)
|
200 |
All |
16 Years and older (Child, Adult, Senior) |
NCT03145961 |
ICR-CTSU/2016/10058
2017-000508-92 |
c-TRAK-TN |
December 21, 2017 |
June 1, 2021 |
December 1, 2022 |
May 9, 2017 |
January 29, 2018 |
|
- Royal Marsden Hospital, Chelsea
Chelsea, London, United Kingdom - Royal Marsden Hospital, Sutton
Sutton, Surrey, United Kingdom - Queen Elizabeth Hospital
Birmingham, United Kingdom - (and 14 more...)
|
| 39 |
NCT03055312 |
Recruiting |
Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer |
- Metastatic Triple Negative Breast Cancer
|
- Drug: TPC
- Drug: Bicalutamide 150 mg
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Clinical benefit rate for 16 weeks
- progression-free survival
|
262 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03055312 |
SYSUCC-007 |
SYSUCC-007 |
December 2016 |
December 2020 |
December 2020 |
February 16, 2017 |
September 11, 2017 |
|
- Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China - Sun Yat-sen University, Cancer Center
Guangzhou, Guangdong, China
|
| 40 |
NCT02834403 |
Recruiting |
L-NMMA Plus Docetaxel in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients |
- Metastatic Triple Negative Breast Cancer
|
- Drug: L-NMMA
- Drug: Docetaxel
- Drug: Amlodipine
- Drug: Pegfilgrastim
|
Interventional |
Phase 1
Phase 2 |
- Polly A. Niravath, MD
- The Methodist Hospital System
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- MTD
- Clinical Benefit Rate
- DLTs and other adverse events
- (and 3 more...)
|
48 |
Female |
18 Years and older (Adult, Senior) |
NCT02834403 |
Pro00011685 |
|
July 2016 |
August 2019 |
August 2019 |
July 15, 2016 |
March 29, 2018 |
|
- Houston Methodist Hospital
Houston, Texas, United States
|
| 41 |
NCT02819518 |
Recruiting |
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355) |
- Triple Negative Breast Cancer (TNBC)
|
- Biological: Pembrolizumab
- Drug: Nab-paclitaxel
- Drug: Paclitaxel
- (and 3 more...)
|
Interventional |
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Part 1: Percentage of Participants Who Experience an Adverse Event (AE)
- Part 1: Percentage of Participants Who Discontinue Study Drug Due to an AE
- Part 2: Progression-Free Survival (PFS) - All Participants
- (and 11 more...)
|
858 |
All |
18 Years and older (Adult, Senior) |
NCT02819518 |
3475-355
2016-001432-35
163422
MK-3475-355 |
|
July 27, 2016 |
December 30, 2019 |
December 30, 2019 |
June 30, 2016 |
March 22, 2018 |
|
- Roy and Patricia Disney Family Cancer Center ( Site 0085)
Burbank, California, United States - St. Joseph Heritage Healthcare ( Site 0093)
Fullerton, California, United States - Loma Linda University Cancer Center ( Site 0075)
Loma Linda, California, United States - (and 248 more...)
|
| 42 |
NCT03348098 |
Recruiting |
Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer |
- Triple Negative Breast Cancer
|
- Drug: Apatinib
- Drug: Paclitaxel
|
Interventional |
Phase 2 |
- Tianjin Medical University Cancer Institute and Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
20 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT03348098 |
AHEAD TB001 |
|
September 6, 2017 |
July 6, 2018 |
December 6, 2018 |
November 20, 2017 |
November 28, 2017 |
|
- TianJin Medical University Cancer Institute and Hospital
Tianjin, China
|
| 43 |
NCT02422498 |
Recruiting |
Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy |
- Locally Recurrent/Metastatic Triple Negative Breast Cancer
|
- Radiation: external beam radiation therapy
- Drug: cisplatin
- Procedure: Biopsy of Target Tumor
|
Interventional |
Phase 2 |
- Memorial Sloan Kettering Cancer Center
- Cedars-Sinai Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- response (RECIST 1.1 vs. PET Response Criteria (PRC) as measurement tools for treatment response)
|
54 |
Female |
18 Years and older (Adult, Senior) |
NCT02422498 |
15-032 |
|
April 2015 |
April 2019 |
April 2019 |
April 21, 2015 |
January 12, 2018 |
|
- Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States - (and 3 more...)
|
| 44 |
NCT02926690 |
Recruiting |
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer |
- Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer
|
|
Interventional |
Phase 1 |
- OncoTherapy Science, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
70 |
All |
18 Years and older (Adult, Senior) |
NCT02926690 |
OTS1070103 |
|
May 29, 2017 |
January 2020 |
April 2020 |
October 6, 2016 |
July 2, 2017 |
|
- Weill Cornell Medicine | NewYork-Presbyterian
New York, New York, United States - MD Anderson Cancer Center
Houston, Texas, United States
|
| 45 |
NCT03362060 |
Recruiting |
PVX-410 Vaccine Plus Pembrolizumab in HLA-A2+ Metastatic Triple Negative Breast Cancer |
- Triple Negative Breast Cancer
- Metastatic Breast Cancer
|
- Drug: Pembrolizumab
- Biological: PVX-410
|
Interventional |
Phase 1 |
- Massachusetts General Hospital
- Merck Sharp & Dohme Corp.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Immune Response following treatment with PVX-410 in combination with pembrolizumab
- Late Immune response after treatment with PVX-410 and pembrolizumab
- Incidence of treatment emergent adverse events (safety and tolerability) of PVX-410 in combination with pembrolizumab
- (and 6 more...)
|
20 |
Female |
18 Years and older (Adult, Senior) |
NCT03362060 |
17-328 |
|
December 12, 2017 |
December 31, 2020 |
December 31, 2024 |
December 5, 2017 |
April 9, 2018 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - Dana Farber Cancer Institute
Boston, Massachusetts, United States
|
| 46 |
NCT01216124 |
Available |
Efficacy and Safety Study of Neoadjuvant Chemotherapy for Local Advanced Triple Negative Breast Cancer Patients |
- Triple Negative Local Advanced Breast Cancer
|
- Drug: docetaxel oxaliplatin
|
Expanded Access |
|
- Fudan University
- Chinese Anti-Cancer Association
|
Other |
|
|
|
Female |
18 Years to 65 Years (Adult) |
NCT01216124 |
Fudan TNBC Neo CT |
|
|
|
|
October 7, 2010 |
October 7, 2010 |
|
|
| 47 |
NCT03243331 |
Recruiting |
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer |
- Triple Negative Breast Cancer
- Metastatic Breast Cancer
|
- Drug: Gedatolisib
- Drug: PTK7-ADC
|
Interventional |
Phase 1 |
- Kathy Miller
- Indiana University
|
Other |
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of Gedatolisb + PTK7-ADC using NCI CTCAE v4.0
- Efficacy in all enrolled subjects
- Overall response rate in all enrolled subjects
- (and 3 more...)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT03243331 |
IUSCC-0613 |
|
January 19, 2018 |
August 1, 2019 |
January 1, 2020 |
August 9, 2017 |
February 12, 2018 |
|
- IU Simon Cancer Center
Indianapolis, Indiana, United States
|
| 48 |
NCT03186937 |
Recruiting |
A Window of Opportunity Study of Methionine Deprivation in Triple Negative Breast Cancer |
- Breast Cancer
- Triple Negative Breast Cancer
|
- Dietary Supplement: hominex-2
|
Interventional |
Phase 2 |
- University of Wisconsin, Madison
- National Cancer Institute (NCI)
- Avon Foundation
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Change in cell surface expression of TRAIL receptor-2
- Safety and tolerability of methionine measured by number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- Effect of methionine restriction on cancer stem cell markers CD44 and CD24
- (and 6 more...)
|
25 |
Female |
18 Years and older (Adult, Senior) |
NCT03186937 |
UW16083
2016-1532
P30CA014520
NCI-2017-01047 |
|
August 10, 2017 |
June 30, 2018 |
June 30, 2019 |
June 14, 2017 |
September 6, 2017 |
|
- University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
|
| 49 |
NCT02348320 |
Recruiting |
Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy |
- Triple Negative Breast Cancer
- Triple-Negative Breast Cancer
- Triple Negative Breast Neoplasms
|
- Biological: Personalized polyepitope DNA vaccine
|
Interventional |
Phase 1 |
- Washington University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of the personalized polyepitope DNA vaccine strategy, measured by both clinical observation and laboratory evaluation
- Immunogenicity of the personalized polyepitope DNA vaccine strategy, measured by ELISPOT analysis, a surrogate for CD8 T cell function, and multiparametric flow cytometry
|
30 |
Female |
18 Years and older (Adult, Senior) |
NCT02348320 |
201505074 |
|
June 17, 2015 |
June 30, 2019 |
June 30, 2019 |
January 28, 2015 |
March 29, 2018 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States
|
| 50 |
NCT02802423 |
Not yet recruiting |
A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Docetaxel Monotherapy in Patients With Advanced/Metastatic Triple Negative Breast Cancer (TNBC). |
- Triple Negative Breast Cancer
|
- Drug: BLEX 404 Oral Liquid
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase I: Dose-limiting toxicity (DLT) observation
- Phase II: Overall response rate (PR + CR)
- Phase II: Overall response rate (PR + CR)(at least 1 cycle)
- (and 2 more...)
|
44 |
Female |
20 Years to 70 Years (Adult, Senior) |
NCT02802423 |
BLI-1401-2-01 |
|
August 2016 |
June 2018 |
September 2018 |
June 16, 2016 |
June 16, 2016 |
|
|
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