Clinical trials: BRCA1/2 Negative
Triple-Negative Breast Cancer
BRCA and NACT in TNBC Patients
The goal of this observational study is to evaluate data from patients with triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy (NACT) in order to better define the impact of germline BRCA1/2 (gBRCA1/2)…
- Trial name
- Light-Bright (NCT05750719)
- Testing
- BRCA1/2 genetic testing
- Where
- Italy
- Volunteers
- 136 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Breast Cancer
A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
(Neo)adjuvant treatment approaches and outcomes
- Trial name
- ERA (NCT05939128)
- Where
- 19 sites in Russia
- Volunteers
- 625 people
- Sponsor
- AstraZeneca
Breast Cancer
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
- Trial name
- OlympiA (NCT02032823)
- Testing
- Olaparib
- Where
- 698 sites in United States, Argentina and 22 more
- Volunteers
- 1,837 people
- Sponsor
- AstraZeneca
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- ELEMENT (NCT06201234)
- Testing
- Olaparib + Elacestrant, Olaparib
- Where
- 36 sites in Germany
- Volunteers
- 176 people
- Sponsor
- GBG Forschungs GmbH
Metastatic Breast Cancer, Locally Advanced Breast Cancer
HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer
The main purpose of this research study is to learn whether the investigational combination of olaparib, palbociclib, and fulvestrant is safe in patients with estrogen receptor-positive breast cancer and BRCA1 or BRCA2 mutations.
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Advanced Breast Cancer, BRCA2 Mutation
- Trial name
- NCT03685331
- Testing
- Palbociclib, Olaparib, Fulvestrant
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer
PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative…
- Trial name
- NCT01074970
- Testing
- Cisplatin, Rucaparib
- Where
- 27 sites in United States
- Volunteers
- 135 people
- Sponsor
- Hoosier Cancer Research Network
Metastatic Triple Negative Breast Cancer
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and…
- Trial name
- NCT03330847
- Testing
- Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle)., Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).
- Where
- 141 sites in United States, Belgium and 13 more
- Volunteers
- 273 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer With BRCA 1 or BRCA 2 Genetic Mutation, Triple-Negative Breast Cancer
Expanded Access With ABT-888 (Veliparib) to Treat Metastatic Breast Cancer
This is an expanded access protocol to allow continued maintenance therapy with ABT-888 (veliparib) for three patients with metastatic triple negative breast cancer who are currently receiving the investigational product in…
- Trial name
- NCT02985658
- Testing
- Veliparib, Cisplatin, Vinorelbine
- Where
- United States
- Sponsor
- University of Washington
BRCA1 Mutation Carrier, BRCA2 Mutation Carrier
mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian
This phase Ib/II trial studies the side effects and best dose of olaparib and vistusertib (AZD2014) or olaparib and capivasertib (AZD5363) when given together in treating patients with endometrial, triple negative breast cancer…
- Conditions
- BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Endometrial Adenocarcinoma, Estrogen Receptor Negative
- Trial name
- NCT02208375
- Testing
- Capivasertib, Laboratory Biomarker Analysis, Olaparib
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- M.D. Anderson Cancer Center
BRCA1/2 Negative
Multiplex Testing for Evaluation of Breast Cancer Risk, Longitudinal Study
The overall goal of the proposed research is to evaluate the uptake of testing and longitudinal risks and benefits of multiplex testing for cancer susceptibility in BRCA1/2 negative patients.
- Trial name
- NCT02514499
- Testing
- Questionnaires
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer, PALB2-Mutated Breast Carcinoma
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative…
- Conditions
- Breast Cancer, PALB2-Mutated Breast Carcinoma, HER2-negative Breast Cancer, BRCA1 Mutation
- Trial name
- NCT06488378
- Testing
- Axatilimab, Olaparib
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Triple Negative Breast Neoplasms
Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency
This is a multicenter, prospective, randomized, open-label phase II study evaluating the efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast cancer in patients with HR deficiency.
- Conditions
- Breast Cancer, Triple Negative Breast Neoplasms, HRpos Breast Neoplasms, BRCA 1 /2 and / or HRD
- Trial name
- GeparOla (NCT02789332)
- Testing
- PwO, PwCb, EC
- Where
- 12 sites in Germany
- Volunteers
- 107 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer (Early Breast Cancer), BRCA 1 Gene Mutation
Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in BRCA-associated Triple-negative Locally Advanced Breast Cancer
This study was designed to evaluate the safety and efficacy of neoadjuvant therapy with mitomycin and carboplatin in patients with BRCA-associated locally advanced triple-negative breast cancer.
- Conditions
- Breast Cancer (Early Breast Cancer), BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- MCarb-T (NCT07821229)
- Testing
- Neoadjuvant Chemotherapy (NACT)
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- N.N. Petrov National Medical Research Center of Oncology
Breast Cancer, Ovarian Cancer
AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer
Background: Carboplatin is approved by the Food and Drug Administration to treat cancer. AZD2281 is an experimental drug in a class of agents called PARP inhibitors.
- Trial name
- NCT01445418
- Testing
- AZ2281 + Carboplatin
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- National Cancer Institute (NCI)
Platinum-sensitive, TNBC, Triple Negative Breast Cancer
A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance
Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations.
- Conditions
- Platinum-sensitive, TNBC, Triple Negative Breast Cancer, BRCA1/2 Mutation or Not
- Trial name
- Fzp-MA-TNBC (NCT07321015)
- Testing
- Fluzoparib Monotherapy
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Cancer, Ovarian Cancer
Phase I Clinical Trials Investigating the Potential Efficacy of Axitinib in Patients With a BRCA 1/2 Mutations
This Clinical Trial is investigating the potential efficacy of axitinib after genetic testing in BRCA 1/2 Mutation patients, regardless of HER2 expression, who have progressed after at least one line of standard treatment or for…
- Conditions
- Breast Cancer, Ovarian Cancer, Breast Neoplasms, Ovarian Neoplasms
- Trial name
- NCT05904730
- Testing
- Axitinib
- Where
- 2 sites in Ukraine
- Volunteers
- 10 people
- Sponsor
- Lynkcell Europe
Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma
Niraparib and Selenium for the Treatment of Recurrent BRCA Negative Platinum Resistant Ovarian Cancer
This phase I/II trial tests the safety, side effects and best dose of a combination therapy (niraparib and selenium) in treating patients with BRCA negative ovarian cancer that has come back (recurrent) and does not respond to…
- Conditions
- Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma
- Trial name
- NCT05672095
- Testing
- Biopsy, Biospecimen Collection, Niraparib
- Sponsor
- City of Hope Medical Center
Neoplasms, Breast, Carcinoma of Breast
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
- Conditions
- Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation
- Trial name
- BRAVO (NCT01905592)
- Testing
- niraparib, Physician's choice
- Where
- 104 sites in United States, Belgium and 12 more
- Volunteers
- 216 people
- Sponsor
- Tesaro, Inc.
Metastatic Breast Cancer, Breast Neoplasms
Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m
This non-interventional retrospective study will describe real-world treatment patterns and clinical outcomes among adults with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib as a…
- Trial name
- NCT05141708
- Testing
- Talazoparib
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Pfizer
Solid Tumor, Clear Cell Renal Cell Carcinoma
Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor CB-839 with the poly adenosine diphosphate ribose…
- Conditions
- Solid Tumor, Clear Cell Renal Cell Carcinoma, TNBC - Triple-Negative Breast Cancer, Colorectal Cancer
- Trial name
- NCT03875313
- Testing
- CB-839, Talazoparib
- Where
- 9 sites in United States
- Volunteers
- 33 people
- Sponsor
- Calithera Biosciences, Inc