Clinical trials: BRCA 2 Gene Mutation
BARD1 Gene Mutation, BRCA1 Gene Mutation
Stand up to Cancer: MAGENTA (Making Genetic Testing Accessible)
This randomized clinical trial studies how well online genetics educational video with or without pre- and/or post-telephone genetics counseling works in assessing cancer-risk distress in patients with triple negative breast…
- Conditions
- BARD1 Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation
- Trial name
- NCT02993068
- Testing
- Educational Intervention, Genetic Counseling, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 5,200 people
- Sponsor
- M.D. Anderson Cancer Center
Deleterious BARD1 Gene Mutation, Deleterious BRCA1 Gene Mutation
Surgery in Preventing Ovarian Cancer in Patients With Genetic Mutations
This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer.
- Conditions
- Deleterious BARD1 Gene Mutation, Deleterious BRCA1 Gene Mutation, Deleterious BRCA2 Gene Mutation, Deleterious BRIP1 Gene Mutation
- Trial name
- NCT02760849
- Testing
- Laboratory Biomarker Analysis, Oophorectomy, Quality-of-Life Assessment
- Where
- 9 sites in United States
- Volunteers
- 374 people
- Sponsor
- M.D. Anderson Cancer Center
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
Prostate Cancer Metastatic, Prostate Cancer Recurrent
Molecular Profiling in Prostate Cancer
We aim to employ targeted DNA NGS to evaluate the prevalence of germline and somatic mutations in cancer predisposing genes, such as BRCA1 and BRCA2, and other HR and DDR genes, including also a few additional clinically relevant…
- Conditions
- Prostate Cancer Metastatic, Prostate Cancer Recurrent, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation
- Trial name
- ProProstate (NCT04983628)
- Testing
- Tumor molecular profiling
- Where
- Greece
- Volunteers
- 250 people
- Sponsor
- Hellenic Cooperative Oncology Group
Hereditary Breast and Ovarian Cancer
Study of Quality of Life Post Salpingo-oophorectomy in BRCA1/2 & PALB2 Mutation Carriers (BRCA-HRT)
1. Premenopausal BRCA1 / 2 or PALB2 gene mutation carriers who receive hormone replacement therapy (HRT) after preventive salpingo-oophorectomy (PBSO) have a better quality of sexual, psychological, cardiovascular and bone health…
- Trial name
- BRCA-HRT (NCT05409222)
- Where
- Spain
- Volunteers
- 45 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
BRCA1 Gene Mutation, BRCA2 Gene Mutation
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers
The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves…
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Cancer
- Trial name
- TUBA (NCT02321228)
- Testing
- Salpingectomy with delayed oophorectomy, Risk-reducing salpingo-oophorectomy
- Where
- 13 sites in Netherlands
- Volunteers
- 510 people
- Sponsor
- University Medical Center Nijmegen
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
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
Breast Neoplasms, BRCA 1 Gene Mutation
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or…
- Conditions
- Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- EMBRACA (NCT01945775)
- Testing
- talazoparib, Physician's-Choice
- Where
- 362 sites in United States, Australia and 14 more
- Volunteers
- 431 people
- Sponsor
- Pfizer
Neoplasms, Breast
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and…
- Trial name
- ZEST (NCT04915755)
- Testing
- Niraparib
- Where
- 198 sites in United States, Argentina and 25 more
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
ATM Gene Mutation, BRCA1 Gene Mutation
Niraparib Before Surgery in Treating Patients With High Risk Localized Prostate Cancer and DNA Damage Response Defects
This phase II trial studies how well niraparib, when given before surgery, works in treating patients with high risk prostate cancer that has not spread to other parts of the body (localized) and alterations in deoxyribonucleic…
- Conditions
- ATM Gene Mutation, BRCA1 Gene Mutation, BRCA2 Gene Mutation, BRIP1 Gene Mutation
- Trial name
- NCT04030559
- Testing
- Niraparib, Niraparib Tosylate Monohydrate, Radical Prostatectomy
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of California, Davis
Small Cell Lung Cancer
Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations
This study is a single arm, multi-center phase II study of olaparib monotherapy in patients with relapsed small cell lung cancer (SCLC) harboring HR pathway gene mutations not limited to BRCA 1/2 mutations, ATM deficiency or…
- Trial name
- SUKSES-B (NCT03009682)
- Testing
- Olaparib
- Where
- South Korea
- Volunteers
- 15 people
- Sponsor
- Samsung Medical Center
Pancreatic Neoplasms, Peutz-Jegher's Syndrome
Pancreatic Cancer Screening of High-Risk Individuals in Arkansas
100 subjects who have a family history of pancreatic cancer (PC), or known genetic syndromes associated with increased risk of pancreatic cancer, will be followed for five years.
- Conditions
- Pancreatic Neoplasms, Peutz-Jegher's Syndrome, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- Trial name
- NCT02309632
- Testing
- Pancreatic Cancer Screening Pathway 1, Pancreatic Cancer Screening Pathway 2
- Where
- United States
- Sponsor
- University of Arkansas
Breast Cancer
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy.
- Trial name
- AllodermRCT (NCT00956384)
- Testing
- One-stage dermal matrix/implant procedure, Two-stage tissue expander/implant procedure
- Where
- 4 sites in Canada
- Volunteers
- 198 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
BRCA1 Gene Mutation, BRCA2 Gene Mutation
Prospective Research of Outcomes After Salpingo-oophorectomy
PROSper is a prospective cohort study of 100 women 35-50 years of age with BRCA 1/2 mutations who have elected to either undergo risk reducing salpingo-oophorectomy (RRSO) or nonsurgical management.
- Trial name
- PROSper (NCT01948609)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, San Francisco
BRCA-Mutated Ovarian Carcinoma, BRCA1 Gene Mutation
Olaparib in Treating Patients With Newly Diagnosed BRCA-Mutant Ovarian, Primary Peritoneal, or Fallopian Cancer Before Surgery
This early phase I trial studies how well olaparib works in treating patients with newly diagnosed BRCA-mutant ovarian, primary peritoneal, or fallopian cancer before surgery.
- Conditions
- BRCA-Mutated Ovarian Carcinoma, BRCA1 Gene Mutation, BRCA2 Gene Mutation, High Grade Fallopian Tube Serous Adenocarcinoma
- Trial name
- NCT03943173
- Testing
- Chemotherapy, Olaparib, Therapeutic Conventional Surgery
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- M.D. Anderson Cancer Center
Early Breast Cancer
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
- Trial name
- NCT03499353
- Testing
- TALAZOPARIB
- Where
- 97 sites in United States
- Volunteers
- 61 people
- Sponsor
- Pfizer
BRCA1 Gene Mutation, BRCA2 Gene Mutation
TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
- Conditions
- BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation, RAD51D Gene Mutation
- Trial name
- TUBA-WISP-II (NCT04294927)
- Testing
- Risk-reducing salpingectomy with delayed oophorectomy, Risk-reducing salpingo-oophorectomy
- Where
- 66 sites in United States, Australia and 14 more
- Volunteers
- 3,000 people
- Sponsor
- University Medical Center Nijmegen
Hereditary Breast and Ovarian Cancer Syndrome
Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers
Breast cancer (BC) is a major health problem and the most prevalent cancer among women.In a substantial proportion of familial cases, germ-line mutations in either BRCA1/2 can be detected.
- Trial name
- NCT03162276
- Testing
- Inquiry Based Stress Reduction (IBSR) program, Control
- Where
- 2 sites in Israel
- Volunteers
- 118 people
- Sponsor
- Sheba Medical Center
Fallopian Tube, Primary Peritoneal Cancer
Study of ABT-767 in Subjects With Breast Cancer 1 and Breast Cancer 2 (BRCA 1 and BRCA 2) Mutations and Solid Tumors or High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is a Phase 1, dose escalation trial evaluating the tolerability, pharmacokinetics, and pharmacodynamics of ABT-767 in subjects with advanced Breast Cancer 1 or 2 gene (BRCA1 or BRCA2)-mutated solid tumors and high grade…
- Conditions
- Fallopian Tube, Primary Peritoneal Cancer, Solid Tumors (e.g. Breast, Ovarian, Prostate, or Pancreatic) and Ovarian
- Trial name
- NCT01339650
- Testing
- ABT-767
- Where
- 3 sites in Netherlands
- Volunteers
- 93 people
- Sponsor
- AbbVie (prior sponsor, Abbott)