Clinical trials: BRCA1/2 Mutation, open to volunteers
Genetic Testing, BRCA1/2
Responses to Genetic Risk Modifier Testing Among Women With Pathogenic Variants in Breast Cancer Predisposition Genes
The purpose of this study is to describe how women with BRCA1/2 mutations react to genetic risk modifier testing, and to examine how they make decisions about their healthcare.
- Trial name
- NCT03396341
- Testing
- Salvia sample, Questionnaires, Buccal swab sample
- Where
- 7 sites in United States
- Volunteers
- 806 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
Ovarian Neoplasms, BRCA 1 Gene Mutation
Ovarian Cancer Liquid Biopsy for Early Assessment & Detection in Individuals With BRCA1/2 Pathogenic Variants
The goal of this clinical study is to evaluate the feasibility and acceptability of the Galleri multi-cancer early detection blood test in people with BRCA1 or BRCA2 gene changes who are at high risk for ovarian cancer.
- Conditions
- Ovarian Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Serous Tubal Intraepithelial Carcinoma
- Trial name
- OC-LEAD (NCT07764744)
- Testing
- Galleri Multi-Cancer Early Detection (MCED) Blood Test
- Where
- 2 sites in United States
- Volunteers
- 70 people
- Sponsor
- Weill Medical College of Cornell University
Breast Cancer Susceptibility Gene (BRCA1) Mutation, BRCA2 Mutation
Cognitive Behavioral Therapy for Fear of Cancer Recurrence in Women With BRCA1/2 Gene
The goal of this clinical trial is to determine whether an adapted version of a current cognitive-behavioural group therapy (CBT) protocol for cancer survivors to the specific needs of women who are carriers of the BRCA1/2…
- Conditions
- Breast Cancer Susceptibility Gene (BRCA1) Mutation, BRCA2 Mutation, Fear of Cancer Recurrence
- Trial name
- CBT-FCRBRCA1/2 (NCT06817694)
- Testing
- Cognitive-behavioral group therapy
- Where
- Canada
- Volunteers
- 250 people
- Sponsor
- CHU de Quebec-Universite Laval
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
Triple Negative Breast Neoplasms, Triple Negative Breast Cancer
Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer
This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1/2 mutated triple negative breast…
- Conditions
- Triple Negative Breast Neoplasms, Triple Negative Breast Cancer, Breast Neoplasms, Breast Cancer
- Trial name
- NCT05485766
- Testing
- Pembrolizumab, Paclitaxel, Carboplatin
- Where
- 3 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Okayama University
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
BRCA Mutation, Ovarian Cancer
Prediction of Germline BRCA 1/2 Genes From Healthy Ovaries
The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with…
- Conditions
- BRCA Mutation, Ovarian Cancer, Ultrasound Therapy; Complications
- Trial name
- PROBE-II (NCT05769517)
- Testing
- Germinal BRCA
- Where
- Italy
- Volunteers
- 6,465 people, healthy volunteers welcome
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Tubo-ovarian Carcinoma, High-grade Serous Carcinoma
Risk-reducing Strategies, Including Fimbriectomy, in Women With a Germline Mutation Predisposing to Ovarian or Pelvic Cancer
FIMBRIMENOP-2402 study aims to evaluate the long-term management of cancer risks in premenopausal women who have a genetic predisposition to tubo-ovarian or primary peritoneal carcinoma, such as mutations in BRCA1, BRCA2, RAD51C…
- Conditions
- Tubo-ovarian Carcinoma, High-grade Serous Carcinoma, Primary Peritoneal Carcinoma Stage III, Primary Peritoneal Carcinoma Stage IV
- Trial name
- FIMBRIMENOP (NCT06726330)
- Testing
- Fimbriectomy Followed by Delayed Oophorectomy (F-DO), Bilateral Salpingo-Oophorectomy
- Where
- 23 sites in France
- Volunteers
- 1,100 people
- Sponsor
- Centre Oscar Lambret
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
Breast
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2
- Trial name
- NCT06791161
- Testing
- Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
The Cancer of the Pancreas Screening-5 CAPS5)Study
Johns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.
- Conditions
- Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation, Germline Mutation Carrier
- Trial name
- CAPS5 (NCT02000089)
- Testing
- Secretin, MRI, Tumor marker gene test with CA19-9
- Where
- 9 sites in United States
- Volunteers
- 9,000 people
- Sponsor
- Johns Hopkins University
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
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
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 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
Solid Tumors, Ovarian
First-in-Human, Multicenter, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of YL-18319 Monotherapy in Patients With Locally Advanced/Metastatic Solid Tumors
First-in-Human, multicenter, phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of YL-18319 monotherapy treatment in patients with advanced solid tumors who…
- Trial name
- NCT07903207
- Testing
- YL-18319
- Volunteers
- 45 people
- Sponsor
- Shanghai YingLi Pharmaceutical Co. Ltd.
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
Ovarian Cancer, Breast Cancer
A Bidirectional Cohort Study on Prophylactic Resection Surgery in Populations at Moderate-to-High Risk for Hereditary Ovarian Cancer
The goal of this multi-center observational study is to learn about the effectiveness and safety of different prophylactic (preventive) surgical options in women at moderate-to-high genetic risk for hereditary ovarian cancer…
- Trial name
- NCT07532434
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Peking University Third Hospital
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