Clinical trials: BRCA1 Mutations, open to volunteers
Familial Pancreatic Cancer, BRCA1 Mutation
Registry of Subjects at Risk of Pancreatic Cancer
IRFARPC is a multicenter national registry designed to study the diagnosis and predisposing factors of subjects with an inherited increased risk for pancreatic cancer.
- Conditions
- Familial Pancreatic Cancer, BRCA1 Mutation, BRCA2 Mutation, Lynch Syndrome
- Trial name
- IRFARPC (NCT04095195)
- Testing
- MRCP, Endoultrasonography
- Where
- 4 sites in Italy
- Volunteers
- 1,000 people
- Sponsor
- Associazione Italiana per lo Studio del Pancreas
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
Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer.
- Conditions
- Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma
- Trial name
- SHARON (NCT04150042)
- Testing
- Melphalan, BCNU, Vitamin B12B
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- General Oncology, Inc.
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
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 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
Pancreas Cancer, Pancreatitis
Pancreas Registry and High Risk Registry
The purpose of this study is to establish a registry of patients with pancreatic diseases. Patients included in the registry may include those with: pancreatic cancer, precancerous lesions of the pancreas, inflammatory lesions of…
- Conditions
- Pancreas Cancer, Pancreatitis, Chronic Pancreatitis, Pancreatic Cyst
- Trial name
- NCT02775461
- Where
- 2 sites in United States
- Volunteers
- 1,368 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
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
Prostate Cancer
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations
GENPROS aims to analyse the outcomes of patients with rare gene mutations in the cancer predisposition genes, BRCA1, BRCA2, HOXB13, and Lynch Syndrome, after a diagnosis of and treatment for prostate cancer (PCa).
- Trial name
- GENPROS (NCT02705846)
- Testing
- Observation of treatment outcomes via Questionnaire
- Where
- United Kingdom
- Volunteers
- 4,260 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Pancreatic Cancer
Preliminary Evaluation of Screening for Pancreatic Cancer in Patients With Inherited Genetic Risk
The study is a prospective, observational study evaluating the utility of endoscopic ultrasound or MRI for the identification of preneoplastic and neoplastic pancreatic lesions in patients at high risk for pancreatic cancer…
- Trial name
- NCT02478892
- Testing
- Collection of data from endoscopic ultrasound or MRI/MRCP of the abdomen, Blood sample collection for research
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Advanced Solid Tumor
Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation
This is an open-label, multi-center, phase 1b study designed to determine a tolerable dose of CX-5461 administered by IV infusion on Day 1 and Day 8 of a 28-day cycle in patients with selected solid tumours and associated…
- Trial name
- NCT04890613
- Testing
- CX-5461
- Where
- 8 sites in United States, Canada
- Volunteers
- 52 people
- Sponsor
- Senhwa Biosciences, Inc.
Ovarian Carcinoma
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations.
- Trial name
- NCT04251052
- Testing
- Bilateral Salpingectomy, Bilateral Salpingectomy with Oophorectomy, Biospecimen Collection
- Where
- 574 sites in United States, Canada and 1 more
- Volunteers
- 1,956 people
- Sponsor
- NRG Oncology
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
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.
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
Breast Cancer
Prophylactic Irradiation to the Contralateral Breast for BCAs Patients
Breast cancer is the most common cancer in women worldwide, with high mortality. About 5% to 10% of breast cancers are hereditary.
- Trial name
- PICB (NCT04960839)
- Testing
- Prophylactic contralateral breast irradiation
- Where
- 8 sites in China, Singapore
- Volunteers
- 323 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
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
Pancreatic Cancer Metastatic
Vilastobart+Retifanlimab in BRCA or PALB2 Deficient PC
This is a single arm, open-label, non-randomized multi-institution phase II trial of a Fc enhanced CTLA4 antibody, vilastobart, in combination with PD-1 antibody, retifanlimab, in patients with BRCA1, BRCA2 or PALB2 deficient…
- Trial name
- EKLAVYA-HRD (NCT07765836)
- Testing
- vilastobart (XTX101), Retifanlimab
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital