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Clinical trials for BRCA mutations

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    40 result(s) found for: BRCA mutations. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-002099-18 Sponsor Protocol Number: Veli-BRCA Start Date*: 2011-09-02
    Sponsor Name:Vejle Hospital
    Full Title: Veliparib (ABT888) Monotherapy for Patients with BRCA germline mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer
    Medical condition: BRCA germline mutational and Platinum-Resistant or Partially Platinum-Sensitive Recurrent Epithelial Ovarian Cancer.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033130 Ovarian cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-001213-32 Sponsor Protocol Number: MedOPP168 Start Date*: 2019-02-04
    Sponsor Name:Medica Scientia Innovation Research (MedSIR)
    Full Title: Effectiveness of olaparib plus trastuzumab in HER2-positive BRCA-mutated or Homologous Recombination Deficiency (HRD) advanced breast cancer patients – The OPHELIA Study –
    Medical condition: HER2-positive BRCAmutated or Homologous Recombination Deficiency (HRD) advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005792-12 Sponsor Protocol Number: GOIRC-06-2020 Start Date*: 2022-04-05
    Sponsor Name:GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
    Full Title: Pilot ‘Window of Opportunity’ Neoadjuvant Study of Abemaciclib in Low-Estrogen Receptor (ER) positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative Early Breast Cancer (BC)
    Medical condition: Low-Estrogen Receptor (ER) positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative Early Breast Cancer (BC)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000684-85 Sponsor Protocol Number: PR-30-5010-C Start Date*: 2014-01-14
    Sponsor Name:TESARO UK Limited, (c/o Sisec Limited) [...]
    1. TESARO UK Limited, (c/o Sisec Limited)
    2. TESARO Inc
    Full Title: A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients
    Medical condition: HER2 negative, BRCA germline mutated breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IS (Completed) HU (Completed) BE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) ES (Ongoing) PT (Completed) IT (Completed) FR (Completed) PL (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-002348-27 Sponsor Protocol Number: PH2/052 Start Date*: 2007-10-26
    Sponsor Name:Cancer Research UK
    Full Title: A Cancer Research UK Phase II Proof of Principle Trial of the activity of the PARP-1 inhibitor, AG-014699, in known carriers of a BRCA 1 or BRCA 2 mutation with locally advanced or metastatic breas...
    Medical condition: advanced or metastatic breast or ovarian carcinoma (proven carrier of a mutation in BRCA1 or 2 gene)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003076-12 Sponsor Protocol Number: 673-201 Start Date*: 2014-07-30
    Sponsor Name:Medivation, Inc.
    Full Title: A Phase 2, 2-Stage. 2-Cohort Study of Talazoparib (BMN 673) Administered to Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer
    Medical condition: Locally advanced and/or metastatic breast cancer with germline BRCA1 or BRCA2 mutations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003839-30 Sponsor Protocol Number: D081CC00006 Start Date*: 2014-06-16
    Sponsor Name:AstraZeneca AB
    Full Title: A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germl...
    Medical condition: Adjuvant breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) NL (Ongoing) AT (Trial now transitioned) IS (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-001496-20 Sponsor Protocol Number: ISRCTN43372330 Start Date*: 2008-06-06
    Sponsor Name:University College London
    Full Title: Breakthrough Breast Cancer & Cancer Research UK Genetic Breast Cancer Trial: A randomised phase II pilot trial of carboplatin compared to docetaxel for patients with metastatic genetic breast can...
    Medical condition: Metastatic breast cancer in women with BRCA1 or BRCA 2 mutation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: PT (Completed) SE (Ongoing) ES (Ongoing) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002949-42 Sponsor Protocol Number: PACT-29 Start Date*: 2020-11-27
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: A pilot study of chlorambucil in pre-treated metastatic pancreatic adenocarcinoma patients bearing a germ line BRCA or other DNA Defects Repair (DDR) mutations.
    Medical condition: Patients affected by metastatic pancreatic adenocarcinoma (PDAC).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052747 Adenocarcinoma pancreas PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000617-20 Sponsor Protocol Number: MITO31 Start Date*: 2018-11-14
    Sponsor Name:ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    Full Title: A phase II trial of Olaparib in patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes: The MITO 31 transalational study.
    Medical condition: patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-000298-11 Sponsor Protocol Number: ISS22810078 Start Date*: 2015-09-02
    Sponsor Name:AZIENDA OSPEDALIERA "ISTITUTI OSPITALIERI" DI CREMONA
    Full Title: A phase II, open label, controlled study of olaparib in locally advanced ER, PgR and HER2 negative (Triple Negative) and in locally advanced germline BRCA mutation-positive breast cancer patients: ...
    Medical condition: Locally advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001407-23 Sponsor Protocol Number: GEICAM/2015-06 Start Date*: 2017-01-05
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: A Phase II Clinical Trial to analyse Olaparib Response in patients with BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer (COMETA-Breast study).
    Medical condition: Patients with advanced triple negative breast cancer (TNBC) with BRCA1 and/or BRCA2 promoter methylation assessed in DNA from metastatic lesions and absence of BRCA1 and 2 germline mutations.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2016-002573-35 Sponsor Protocol Number: OZM-058 Start Date*: 2019-08-30
    Sponsor Name:University Health Network, Toronto
    Full Title: A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Patients with Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian tube Cancer.
    Medical condition: Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian tube Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-006459-10 Sponsor Protocol Number: KU36-58 Start Date*: 2007-07-18
    Sponsor Name:KuDOS Pharmaceuticals Ltd. (a member of the AstraZeneca group of companies)
    Full Title: A phase II, open-label, non-comparative, international, multicentre study to assess the efficacy and safety of KU 0059436 given orally twice daily in patients with advanced BRCA1- or BRCA2-associat...
    Medical condition: Advanced ovarian cancer (stage IIIB/IIIC/IV) and confirmed BRCA+ status
    Disease: Version SOC Term Classification Code Term Level
    9.1 10033128 Ovarian cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) SE (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-016846-16 Sponsor Protocol Number: OCTO-16 Start Date*: 2010-12-14
    Sponsor Name:University of Oxford
    Full Title: Phase II Clinical Trial of 6-Mercaptopurine(6MP)and low-dose Methotrexate In Patients With Known BRCA Defective Tumours.
    Medical condition: Advanced or metastatic breast or ovarian cancer.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028985 Neoplasm breast LLT
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002505-35 Sponsor Protocol Number: ABCSG_50 Start Date*: 2018-06-25
    Sponsor Name:ABCSG (Austrian Breast & Colorectal Cancer Study Group)
    Full Title: BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline...
    Medical condition: Prevention of breast cancer in women with a BRCA1 germline mutation
    Disease: Version SOC Term Classification Code Term Level
    21.0 10042613 - Surgical and medical procedures 10036898 Prophylaxis PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    23.0 10010331 - Congenital, familial and genetic disorders 10071980 BRCA1 gene mutation PT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001054-34 Sponsor Protocol Number: D0816C00018 Start Date*: 2018-01-11
    Sponsor Name:AstraZeneca AB
    Full Title: LUCY - Lynparza Breast Cancer Real-World Utility, Clinical Effectiveness and Safety Study A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-...
    Medical condition: Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) HU (Completed) FR (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-004323-72 Sponsor Protocol Number: MedOPP190 Start Date*: 2020-02-05
    Sponsor Name:Medica Scientia Innovation Research (MedSIR)
    Full Title: Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Niraparib plus Aromatase Inhibitors for Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor...
    Medical condition: Advanced or metastatic HR-positive/HER2-negative breast cancer in patients harboring either gBRCAms or gBRCAwt and HRD.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    21.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    20.1 10022891 - Investigations 10077481 Human epidermal growth factor receptor negative PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004366-18 Sponsor Protocol Number: MAZEPPA_D19-02 Start Date*: 2020-03-03
    Sponsor Name:GERCOR
    Full Title: MAZEPPA: Phase II PRODIGE-GERCOR study to evaluate MAintenance therapy with olaparib or selumetinib plus durvalumab according to BRCAness and KRAS somatic status Personalized in metastatic Pancreat...
    Medical condition: Metastatic Pancreatic Adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10033599 Pancreatic adenocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000734-30 Sponsor Protocol Number: D0816C00012 Start Date*: 2015-07-10
    Sponsor Name:AstraZeneca AB
    Full Title: An Open Label, Single Arm, Multicentre Study to Assess the Clinical Effectiveness and Safety of Lynparza (Olaparib) Capsules Maintenance Monotherapy in Platinum Sensitive Relapsed somatic or germli...
    Medical condition: BRCA or HRR+ Mutated Ovarian Cancer Patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended) BG (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
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