Clinical trials: BRCA1/2 Mutation
BRCA1 Mutation, BRCA2 Mutation
Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors
This is a single center, phase I/Ib clinical trial evaluating the combination of the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor olaparib with the DNA methyltransferase (DNMT) inhibitor ASTX727, which is an oral…
- Conditions
- BRCA1 Mutation, BRCA2 Mutation, BRCA Mutation, PALB2 Gene Mutation
- Trial name
- NCT06177171
- Testing
- Olaparib, ASTX727
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Varun Monga, MBBS
Solid Cancers, BRCA Mutation
A PARG Inhibitor DAT-2645 Monotherapy in Patients with Advanced/Metastatic Solid Tumors Harboring BRCA1/2 Loss of Function Alterations And/or Other Defects in the DDR Pathway
The primary objective of the study is to evaluate the safety, tolerability, PK, PD, and prilimary efficacy of a PARG inhibitor DAT-2645 in patients with advanced/metastatic solid tumors harboring BRCA1/2 loss of function…
- Conditions
- Solid Cancers, BRCA Mutation, HRD Cancer, Breast Cancer
- Trial name
- NCT06614751
- Testing
- DAT-2645 tablet
- Where
- 2 sites in China
- Volunteers
- 112 people
- Sponsor
- Danatlas Pharmaceuticals Co., Ltd
Hereditary Breast and Ovarian Cancer Syndrome, BRCA Mutations
Development and Validation of an Ovarian Cancer Risk Prediction Model for Family Members of Ovarian Cancer Probands
Ovarian cancer is the gynecological malignancy with the highest fatality rate, seriously threatening the life and health of women.
- Trial name
- NCT07039552
- Testing
- risk-reducing salpingo-oophorectomy (RRSO)
- Where
- China
- Volunteers
- 10,000 people
- Sponsor
- Peking University Third Hospital
Metastatic Breast Cancer
Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel…
- Trial name
- NCT01506609
- Testing
- Veliparib, Carboplatin, Temozolomide
- Where
- 120 sites in United States, Argentina and 18 more
- Volunteers
- 294 people
- Sponsor
- AbbVie
Women With BRCA 1 or BRCA 2 Mutation, Non-tested Female Family Members
Lessons Learned From the Family Gene Toolkit
Mutations in the BRCA1/2 genes are the primary cause of hereditary breast/ovarian cancer syndrome. Genetic testing identifies mutation carriers and enables them to manage their cancer risk (i.e.
- Trial name
- FGT (NCT02154633)
- Testing
- Family Gene Toolkit, Delayed Family Gene Toolkit
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8
Carboplatin Chemotherapy Before Surgery for People With High-Risk Prostate Cancer and an Inherited BRCA1 or BRCA2 Gene Mutation
This phase II trial tests how well carboplatin before surgery works in treating patients with high-risk prostate cancer and an inherited BRCA1 or BRCA2 gene mutation.
- Conditions
- Prostate Adenocarcinoma, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8
- Trial name
- NCT05806515
- Testing
- Biospecimen Collection, Carboplatin, Chest Radiography
- Where
- 133 sites in United States
- Volunteers
- 44 people
- Sponsor
- SWOG Cancer Research Network
BRCA1 Mutation, BRCA2 Mutation
Promoting Men's Adherence to BRCA1/2 Germline Genetic Testing
BRCA1- and BRCA2-associated Hereditary Breast and Ovarian Cancer Syndrome (HBOC) increases the relative and absolute risk of developing breast and ovarian cancer and, to a lesser extent, prostate and pancreatic cancer.
- Conditions
- BRCA1 Mutation, BRCA2 Mutation, Psychosocial Factors
- Trial name
- BRCA-MEN (NCT04683068)
- Testing
- Message comparison
- Where
- Italy
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- European Institute of Oncology
Advanced Breast Cancer, HER2/Neu Negative
Phase II Trial of Talazoparib in BRCA1/2 Wild-type HER2-negative Breast Cancer and Other Solid Tumors
The aim of this single-arm phase 2 clinical trial is to evaluate the anti-cancer activity of Talazoparib (also known as BMN 673) in patients with advanced breast cancer with specific genetic or tumor genomic alterations.
- Conditions
- Advanced Breast Cancer, HER2/Neu Negative, Triple-Negative Breast Cancer
- Trial name
- NCT02401347
- Testing
- Talazoparib Tosylate
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Melinda Telli
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome
Clinical Impact of Enhanced Risk Assessments in Women With a BRCA1/2 Mutation, CARE Study
This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation.
- Trial name
- NCT06534424
- Testing
- Best Practice, Biospecimen Collection, Counseling
- Where
- 2 sites in United States
- Volunteers
- 152 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
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
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer.
- Conditions
- Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor, FIGO Stage III Ovarian Cancer 2014
- Trial name
- NCT06580314
- Testing
- Bevacizumab, Biospecimen Collection, Computed Tomography
- Where
- 695 sites in United States, Japan and 1 more
- Volunteers
- 880 people
- Sponsor
- NRG Oncology
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
Solid Tumor
A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
- Trial name
- LODESTAR (NCT04171700)
- Testing
- Rucaparib
- Where
- 19 sites in United States
- Volunteers
- 83 people
- Sponsor
- pharmaand GmbH
Ovarian Cancer, Breast Cancer
A Phase II Single Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation Associated Breast or Ovarian Cancer, Triple Negative Breast Cancer, High Grade Serous Ovarian Cancer, and Metastatic Castrate-Resistant Prostate Cancer
Background: All cells go through cycles which allow them to divide. In normal cells, checkpoint kinase 1 (Chk1) and checkpoint kinase 2 (Chk2) (CHEK 2 (Chk1/2) stop cell division at various points to allow any damage to…
- Conditions
- Ovarian Cancer, Breast Cancer, Prostate Cancer
- Trial name
- NCT02203513
- Testing
- LY2606368
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- National Cancer Institute (NCI)
Advanced or Metastatic Solid Tumors, Breast Cancer
A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
The purpose of this study is to characterize the safety, tolerability, and efficacy of IDE161 as a single agent and in combination with pembrolizumab.
- Conditions
- Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Prostate Cancer
- Trial name
- NCT05787587
- Testing
- IDE-161, Pembrolizumab
- Where
- 27 sites in United States
- Volunteers
- 216 people
- Sponsor
- IDEAYA Biosciences
Recurrent Metastatic Melanoma, Cutaneous Melanoma
Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2
The purpose of this study is to evaluate how effective Olaparib is when given as a treatment for primary or recurrent, unresectable or metastatic melanoma. This research study involves targeted therapy.
- Conditions
- Recurrent Metastatic Melanoma, Cutaneous Melanoma, Mucosal Melanoma, Uveal Melanoma
- Trial name
- NCT05482074
- Testing
- Olaparib
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Metastatic Breast Cancer
ABT-888 and Temozolomide for Metastatic Breast Cancer and BRCA1/2 Breast Cancer
The purpose of this research study is to find out if the combination of ABT-888 and temozolomide is safe and effective in treating patients with metastatic breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, BRCA1 Gene Mutation, brca2 Gene Mutation
- Trial name
- NCT01009788
- Testing
- ABT-888, temozolomide
- Where
- 3 sites in United States
- Volunteers
- 63 people
- Sponsor
- Steven J Isakoff, MD, PhD
Breast Cancer Metastatic, BRCA 1 Gene Mutation
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in…
- Conditions
- Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- OlympiAD (NCT02000622)
- Testing
- Olaparib, Physician's choice chemotherapy
- Where
- 171 sites in United States, Bulgaria and 17 more
- Volunteers
- 302 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
Ovarian Cancer
Psychosexual Consequences of Risk-reducing Salpingo-oophorectomy
Short Rationale: Risk-reducing salpingo-oophorectomy (RRSO) is a mainstay in preventing ovarian cancer in BRCA1/2 mutation carriers, as ovarian cancer screening is ineffective in detecting ovarian cancer in an early and curable…
- Trial name
- PURSUE (NCT02372864)
- Testing
- Mindfulness based stress reduction (MBSR)
- Where
- Netherlands
- Volunteers
- 66 people
- Sponsor
- University Medical Center Groningen