Flag of the European Union EU Clinical Trials Register Help

Clinical trials for BRCA gene

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44347   clinical trials with a EudraCT protocol, of which   7375   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    37 result(s) found for: BRCA gene. Displaying page 1 of 2.
    1  2  Next»
    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: 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: 2013-001551-13 Sponsor Protocol Number: D0818C00001 Start Date*: 2013-08-21
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following ...
    Medical condition: BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian 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) NL (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    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: 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: 2018-000345-39 Sponsor Protocol Number: B9991032 Start Date*: 2019-02-19
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumors
    Medical condition: locally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defect
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10065147 Malignant solid tumor LLT
    20.0 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) BE (Completed) DK (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004472-30 Sponsor Protocol Number: MITO23 Start Date*: 2015-12-02
    Sponsor Name:FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
    Full Title: Randomized phase III trial on Trabectedin (ET-743) vs clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients
    Medical condition: recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006888 Ca ovary LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) ES (Prematurely Ended)
    Trial results: (No results available)
    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: 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: 2018-003832-57 Sponsor Protocol Number: UC-0140/1812 Start Date*: 2019-02-28
    Sponsor Name:UNICANCER
    Full Title: DOLAF- An international multicenter phase I/II trial of Durvalumab (MEDI4736) plus OLAparib plus Fulvestrant in metastatic or locally advanced ER-positive, HER2-negative breast cancer patients sele...
    Medical condition: ER-positive and HER2-negative metastatic or locally advanced breast cancer with either a germline or somatic BRCA mutation, or a deleterious alteration of other genes involved in homologous recombi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10072740 Locally advanced breast cancer LLT
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    20.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned)
    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: 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: 2017-002808-28 Sponsor Protocol Number: OZM-061 Start Date*: 2017-12-29
    Sponsor Name:Princess Margaret Cancer Centre
    Full Title: Olala Trial: A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
    Medical condition: epithelial ovarian cancer (including fallopian tube or peritoneal cancer)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061328 Ovarian epithelial cancer PT
    Population Age: Adults, Elderly Gender: 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: 2018-003612-45 Sponsor Protocol Number: A9001502 Start Date*: 2019-09-06
    Sponsor Name:Pfizer Inc.
    Full Title: TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
    Medical condition: Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-000630-17 Sponsor Protocol Number: MER-XMT-1536-1 Start Date*: 2021-09-21
    Sponsor Name:Mersana Therapeutics, Inc.
    Full Title: A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b
    Medical condition: High grade serous ovarian cancer or non-small cell lung cancer (NSCLC), adenocarcinoma subtype
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NO (Completed) LT (Completed) CZ (Completed) HU (Completed) BG (Completed) FI (Completed) PL (Completed) DK (Completed) IT (Completed) AT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003355-38 Sponsor Protocol Number: D0816C00025 Start Date*: 2019-12-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I, Open-label, Parallel Group Study to Investigate Olaparib Safety and Tolerability, Efficacy and Pharmacokinetics in Paediatric Patients with Solid Tumours
    Medical condition: Solid Tumours
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Ongoing) DK (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) AT (Prematurely Ended) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003438-20 Sponsor Protocol Number: D0816C00010 Start Date*: 2015-01-15
    Sponsor Name:Astra Zeneca AB
    Full Title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician’s Choice Single Agent Chemotherapy in the Treatment of...
    Medical condition: Platinum Sensitive Relapsed Ovarian 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: HU (Completed) BE (Completed) CZ (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-006458-91 Sponsor Protocol Number: KU36-44 Start Date*: 2007-05-22
    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 breast cancer (stage IIIB/IIIC/IV) and confirmed BRCA+ status
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006187 Breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Completed) ES (Ongoing) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002377-21 Sponsor Protocol Number: M14-011 Start Date*: 2014-11-17
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant...
    Medical condition: Triple Negative Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) HU (Completed) GB (GB - no longer in EU/EEA) ES (Completed) IT (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun Jul 06 14:10:17 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA