Clinical trials: BRCA1 Mutation
Ovarian Cancer
BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment
Background: The new drug BMN 673 (talazoparib) has been shown to fight tumor cells in animals and some people. It is a poly (ADP-ribose) polymerase (PARP) inhibitor.
- Trial name
- NCT02326844
- Testing
- BMN 673 (talazoparib)
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- National Cancer Institute (NCI)
Ovarian Cancer, Fallopian Tube Cancer
PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer
Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1…
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
- Trial name
- NCT02571725
- Testing
- Olaparib, Tremelimumab
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- New Mexico Cancer Research Alliance
Breast Cancer
Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1) Expression as Biomarker of PARP Inhibitor Resistance in Patients With Deleterious Germline Mutation in BRCA 1/2 and HER2-negative, Metastatic or Locally Advanced Breast Cancer.
The purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in…
- Trial name
- REPARP (NCT05378204)
- Testing
- Main study:, Sub-study:
- Where
- 25 sites in France
- Volunteers
- 120 people
- Sponsor
- Institut Claudius Regaud
Advanced Solid Tumors, Breast Cancer Recurrent
First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients With Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers
The goal of this study is to identify a safe and tolerated dose of the orally administered DHX9 inhibitor ATX-559. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of…
- Conditions
- Advanced Solid Tumors, Breast Cancer Recurrent, Colorectal Cancer Metastatic, Colon Cancer
- Trial name
- NCT06625515
- Testing
- ATX-559
- Where
- 5 sites in United States
- Volunteers
- 17 people
- Sponsor
- Accent Therapeutics
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
Pancreatic Cancer
Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the experimental study drug rucaparib (also known as CO-338) on subjects and on their pancreatic…
- Trial name
- NCT03140670
- Testing
- RUCAPARIB
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Advanced Solid Tumors
A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.
The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-428 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or…
- Trial name
- NCT07356453
- Testing
- FORX-428
- Where
- 8 sites in United States
- Volunteers
- 40 people
- Sponsor
- FoRx Therapeutics AG
BRCA-Associated Breast Carcinoma
Breast Cancer After Ovarian Cancer During and/or After Therapy: Genomic Evaluation
This study will investigate, in patients with germline BRCA-1/2 mutations and breast cancer, arising during and / or after treatment with platinum-based chemotherapy and / or with PARP-inhibitors for ovarian cancer, the presence…
- Trial name
- Gen-eva (NCT05763472)
- Testing
- Next-generation sequencing (NGS) assay TruSight Oncology 500 (TSO 500).
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer
This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic).
- Conditions
- Advanced Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8
- Trial name
- NCT04090567
- Testing
- Cediranib, Ceralasertib, Olaparib
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Neoplasms, BRCA 1 Gene Mutation
A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or…
- Conditions
- Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- ABRAZO (NCT02034916)
- Testing
- talazoparib
- Where
- 71 sites in United States, France and 3 more
- Volunteers
- 84 people
- Sponsor
- Pfizer
Breast Cancer
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal…
- Trial name
- NCT02561832
- Testing
- Olaparib, Carboplatin, Anthracycline
- Where
- 7 sites in United States, Spain
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Body Mass Index 25 or Greater, BRCA1 Gene Mutation
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients…
- Conditions
- Body Mass Index 25 or Greater, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Breast Carcinoma
- Trial name
- NCT02194387
- Testing
- Dietary Intervention, Internet-Based Intervention, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- M.D. Anderson Cancer Center
Triple-negative Breast Cancer
PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC
In TNBC patients who have completed neoadjuvant immunotherapy and local treatment, a 9-cycle regimen of PD-1 inhibitor adjuvant immunotherapy is currently considered the standard approach.
- Trial name
- NCT06533384
- Testing
- As per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy., 9 cycles of Camrelizumab as adjuvant therapy.
- Where
- China
- Volunteers
- 310 people
- Sponsor
- Guangdong Provincial People's Hospital
Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments
Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at…
- Trial name
- SOLO3 (NCT02282020)
- Testing
- OLAPARIB, Single agent chemotherapy
- Where
- 94 sites in United States, Argentina and 11 more
- Volunteers
- 266 people
- Sponsor
- AstraZeneca
Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations
This is an open label, phase II trial in subjects with treatment naïve, metastatic hormone sensitive prostate cancer (mHSPC) with deleterious homologous recombination repair (HRR) alteration(s).
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC), Deleterious HRR Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Trial name
- HARMONY (NCT06392841)
- Testing
- Androgen Deprivation Therapy (ADT), Niraparib/Abiraterone Acetate DAT, Abiraterone Acetate
- Sponsor
- Qian Qin
BRCA1 Mutation, BRCA2 Mutation
BRCA Founder OutReach (BFOR) Study
The purpose of this study is to learn how to provide BRCA gene testing to a larger number of people as well as to make testing part of a person's regular medical care.
- Trial name
- BFOR (NCT03351803)
- Testing
- BFOR Digital Health solution/Web Portal
- Where
- 5 sites in United States
- Volunteers
- 5,412 people, healthy volunteers welcome
- Sponsor
- Memorial Sloan Kettering Cancer Center
Lobular Breast Carcinoma, Lobular in Situ Breast Carcinoma
LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients
This is a cross-sectional and retrospective study of a cohort of patients with invasive lobular breast cancer (LBC) or in situ lobular neoplasia (LIN3).
- Conditions
- Lobular Breast Carcinoma, Lobular in Situ Breast Carcinoma, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- LobularCard (NCT05410951)
- Testing
- Illumina panel
- Where
- Italy
- Volunteers
- 800 people
- Sponsor
- European Institute of Oncology
To Investigate the Prevalence of BRCA 1/2 Mutation Among Ovarian Cancer
BRCA 1/2 Mutation in Korean Patients With Epithelial Ovarian Cancer
PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2 mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial ovarian cancer (EOC).
- Trial name
- NCT02963688
- Testing
- Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform
- Volunteers
- 298 people
- Sponsor
- Samsung Medical Center
BRCA1 Gene Mutation, BRCA2 Gene Mutation
Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation
This phase I/II trial studies the side effects and best dose of olaparib when give together with durvalumab and tremelimumab and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal…
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Serous Adenocarcinoma, Recurrent Fallopian Tube Carcinoma
- Trial name
- NCT02953457
- Testing
- Durvalumab, Laboratory Biomarker Analysis, Olaparib
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Roswell Park Cancer Institute
Prostate Cancer, Hereditary Prostate Cancer
Targeted Prostate Cancer Screening in Men With BRCA1/2 Mutations
This interventional study is a follow-up component of the IMPACT project, which aims to identify men at increased hereditary risk of prostate cancer.
- Trial name
- IMPACT (NCT07416812)
- Testing
- Targeted Prostate Cancer Screening, Telephone Follow-Up Interview
- Where
- Slovenia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Institute of Oncology Ljubljana