Clinical trials: BRCA1/2
Breast Cancer
Genetic Risk Estimations for Influencing Decision Making in Women at High Risk of Breast Cancer, GENRE 2 Study
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast…
- Trial name
- GENRE2 (NCT04474834)
- Testing
- Polygenic Risk Score
- Where
- 5 sites in United States
- Volunteers
- 737 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
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
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
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
Breast Cancer
PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative…
- Trial name
- NCT01074970
- Testing
- Cisplatin, Rucaparib
- Where
- 27 sites in United States
- Volunteers
- 135 people
- Sponsor
- Hoosier Cancer Research Network
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
- NCT01367639
- Testing
- Inquiry Based Stress Reduction (IBSR) program
- Where
- Israel
- Volunteers
- 67 people
- Sponsor
- Sheba Medical Center
Ovarian Carcinoma
Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophorectomy
This randomized pilot early phase I trial studies how well denosumab works in BRCA1/2 mutations carriers scheduled for risk-reducing salpingo-oophorectomy.
- Trial name
- NCT03382574
- Testing
- Denosumab, Salpingo-Oophorectomy
- Where
- 6 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer, Genetic Predisposition
Psyco Quality of Life and Procreation BRCA1/2
Women with breast and/or ovarian cancer or with a family history carried these pathologies can makeo genetic counseling in order to investigate whether they are carriers of the BRCA1/2 genetic mutation.
- Trial name
- QoL (NCT05857670)
- Testing
- Genetic predisposition to breast cancer
- Where
- 2 sites in Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Regina Elena Cancer Institute
Ovarian Cancer
Impact of Different BRCA1/2 Gene Variants on Response to Therapy and Prognosis of Ovarian Cancer
Identify any significant differences in terms of drug response and survival between the different possible alterations in the BRCA1/2 genes, in order to stratify ovarian cancer patients with a view to increasingly personalised…
- Trial name
- NCT06775470
- Testing
- Patients must have been diagnosed with ovarian cancer and be BRCA positive, BRCA1 and BRCA2 positive, and be affected by Ovarian Cancer
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Metastatic Triple Negative Breast Cancer
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and…
- Trial name
- NCT03330847
- Testing
- Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle)., Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).
- Where
- 141 sites in United States, Belgium and 13 more
- Volunteers
- 273 people
- Sponsor
- AstraZeneca
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
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
BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary
The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer.
- Trial name
- NCT06304922
- Testing
- Assess the response to platinum-based chemotherapy in correlation to BRCA status in neoadjuvant and recurrent ovarian cancer
- Volunteers
- 45 people
- Sponsor
- Assiut University
BRCA1 Mutation Carrier, BRCA2 Mutation Carrier
mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian
This phase Ib/II trial studies the side effects and best dose of olaparib and vistusertib (AZD2014) or olaparib and capivasertib (AZD5363) when given together in treating patients with endometrial, triple negative breast cancer…
- Conditions
- BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Endometrial Adenocarcinoma, Estrogen Receptor Negative
- Trial name
- NCT02208375
- Testing
- Capivasertib, Laboratory Biomarker Analysis, Olaparib
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- M.D. Anderson Cancer Center
Prostatic Neoplasms
Men at High Genetic Risk for Prostate Cancer
Background: Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated…
- Trial name
- NCT03805919
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- National Cancer Institute (NCI)
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
Ovarian Neoplasms, BRCA1 Protein
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours.
- Conditions
- Ovarian Neoplasms, BRCA1 Protein, BRCA2 Protein
- Trial name
- NCT00516373
- Testing
- KU-0059436 (AZD2281)(PARP inhibitor)
- Where
- 5 sites in Belgium, Netherlands and 2 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ
Identifying and Caring for Individuals With Inherited Cancer Syndrome
This trial examines approaches to identify and care for individuals with inherited cancer syndrome. The purpose of this study is to offer no cost genetic testing to the general public.
- Conditions
- BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome, Breast Ductal Carcinoma In Situ, Hematopoietic and Lymphoid System Neoplasm, Hereditary Neoplastic Syndrome
- Trial name
- NCT04494945
- Testing
- Biospecimen Collection, Genetic Counseling, Genetic Testing
- Where
- 2 sites in United States
- Volunteers
- 27,500 people, healthy volunteers welcome
- Sponsor
- OHSU Knight Cancer Institute
Ovarian Cancer, Fallopian Tube Cancer
Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
To investigate the frequency and clinical significance of Homologous Recombination Deficiency (HRD) in Japanese patients with ovarian cancer (including Fallopian tube cancer and primary peritoneal cancer).
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- Trial name
- HITOMI (NCT03159572)
- Where
- Japan
- Volunteers
- 996 people
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan