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Clinical trials for 2017-002505-35

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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    The EU Clinical Trials Register currently displays   44366   clinical trials with a EudraCT protocol, of which   7389   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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    1 result(s) found for: 2017-002505-35. Displaying page 1 of 1.
    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)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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.

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