Clinical trials: BRCA1 Mutation
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
Breast Carcinoma, Genetic Predisposition to Cancer
MEASUREMENT OF CIRCULATING MUTATION BURDEN
Cancer-free women with a hereditary predisposition to breast and/or ovarian cancer
- Conditions
- Breast Carcinoma, Genetic Predisposition to Cancer, BRCA Mutation, cfMB
- Trial name
- cRISK (NCT06792721)
- Testing
- Mutation Burden cfMB analysis
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Centre Francois Baclesse
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
Ovarian Epithelial Cancer, Carcinoma in Situ
Early Detection of High Grade Ovarian Cancer Using Uterine Lavage EHUD Study and Duplex Sequencing
In Phase I the sponsor will systematically test conditions for lavage filtration that increase tumor cell fraction without reducing tumor mutation yield.
- Conditions
- Ovarian Epithelial Cancer, Carcinoma in Situ, Ovarian Cancer
- Trial name
- EHUD (NCT04823871)
- Testing
- Speiser-catheter for uterine and tubal lavage
- Where
- 9 sites in Austria, Czechia and 2 more
- Volunteers
- 406 people
- Sponsor
- Paul Speiser, Prof.MD,
Women With Mutations in the Breast Cancer Susceptibility Genes BRCA1,2
BRCA1/2 and Effect of Mifepristone on the Breast
Ovarian steroids, as well as their synthetic counterparts gestagens and estrogens have a role in breast cell proliferation and the development of breast cancer.
- Trial name
- NCT01898312
- Testing
- Mifepristone
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- Karolinska Institutet
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
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
BRCA1 Mutation, Breast Cancer
Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of recombinant human chorionic gonadotropin may prevent breast cancer in premenopausal women with BRCA1 mutations.
- Trial name
- NCT00700778
- Testing
- recombinant human chorionic gonadotropin, microarray analysis, immunohistochemistry staining method
- Where
- 3 sites in United States, Austria
- Volunteers
- 2 people
- Sponsor
- Fox Chase Cancer Center
Surgical Menopause, BRCA1 Mutation
Health After eaRly Menopause Due to Oophorectomy
Risk-Reducing Salpingo-Oophorectomy (RRSO) at the age of 35 to 45 years is recommended for women with a high genetic risk for ovarian cancer.
- Conditions
- Surgical Menopause, BRCA1 Mutation, BRCA2 Mutation, Cardiovascular Diseases
- Trial name
- HARMOny (NCT03835793)
- Testing
- CAC-score
- Where
- Netherlands
- Volunteers
- 750 people
- Sponsor
- The Netherlands Cancer Institute
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- SPrNSM (NCT04866992)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Breast Cancer, Ovarian Cancer
Thymidine Kinase 1 in Risk Assessment for Hereditary Breast /Ovarian Cancer
This study aimed to compare the activity of Thymidine Kinase 1 in serum of two groups of woman at high and normal risk for breast/ovary cancer.
- Trial name
- NCT00855998
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization
brca1 Mutation Carrier, brca2 Mutation Carrier
Deslorelin Combined With Low-Dose Add-Back Estradiol and Testosterone in Preventing Breast Cancer in Premenopausal Women Who Are at High Risk for This Disease
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Deslorelin combined with low-dose add-back estradiol and testosterone (given to replace hormones suppressed…
- Conditions
- brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
- Trial name
- NCT00080756
- Testing
- therapeutic estradiol, deslorelin, therapeutic testosterone
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- City of Hope Medical Center
Metastatic Breast Cancer, Invasive Breast Cancer
Olaparib In Metastatic Breast Cancer
This research study is for patients with metastatic breast cancer. Metastatic means that the cancer has spread beyond the breast.
- Conditions
- Metastatic Breast Cancer, Invasive Breast Cancer, Somatic Mutation Breast Cancer (BRCA1), Somatic Mutation Breast Cancer (BRCA2)
- Trial name
- NCT03344965
- Testing
- Olaparib
- Where
- 20 sites in United States
- Volunteers
- 114 people
- Sponsor
- Beth Israel Deaconess Medical Center
Breast Cancer, BRCA1 Mutation
IMpact of Breast cAncer Gene Status on Survival in Adjuvant Breast Cancer (IMBASSA)
Relationship between the presence of the BRCA mutation (BReast Cancer) and outcomes is unclear in high-risk early breast cancers (BC).
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- IMBASSA (NCT04012229)
- Testing
- BRCA mutation
- Where
- France
- Volunteers
- 2,295 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Besancon
Gynecologic Cancer, Breast Cancer
Web-based Family History Tool
The purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting.
- Conditions
- Gynecologic Cancer, Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- Progeny (NCT04890327)
- Testing
- Web-based family health history tool
- Where
- United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
HER2-negative Breast Cancer, Metastatic Breast Cancer
Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.
The primary objetive is to assess the capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1).
- Conditions
- HER2-negative Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- RADIOLA (NCT05340413)
- Testing
- Olaparib
- Where
- 5 sites in Spain
- Volunteers
- 65 people
- Sponsor
- SOLTI Breast Cancer Research Group
Prostate Cancer, BRCA1 Mutation
Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations
Phase 2 open-label, single-arm clinical trial evaluating the efficacy and safety of neoadjuvant olaparib + LHRH agonist administered for 6 months prior to radical prostatectomy (RP) in men with unfavorable intermediate-risk or…
- Conditions
- Prostate Cancer, BRCA1 Mutation, BRCA2 Mutation, Prostatic Adenocarcinoma
- Trial name
- NePtune (NCT05498272)
- Testing
- Olaparib, LHRH agonist
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Rana McKay, MD
Breast Cancer
Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by…
- Trial name
- NCT04987931
- Testing
- Talazoparib
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Pfizer
Ovarian Cancer
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer
This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.
- Trial name
- NCT03509636
- Testing
- Fluzoparib
- Where
- China
- Volunteers
- 113 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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