Flag of the European Union EU Clinical Trials Register Help

Clinical trials for 2013-001040-62

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   44365   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 ).  
     
    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
     
    1 result(s) found for: 2013-001040-62. Displaying page 1 of 1.
    EudraCT Number: 2013-001040-62 Sponsor Protocol Number: GBG78/BIG1-13 Start Date*: 2013-11-14
    Sponsor Name:GBG Forschungs GmbH
    Full Title: Phase III study evaluating palbociclib (PD-0332991), a cyclin-dependent kinase (CDK) 4/6 inhibitor, in patients with hormone-receptor positive, HER2 normal primary breast cancer with high relapse r...
    Medical condition: About one-third of patient with hormone-receptor positive, HER2 negative breast cancer and residual disease after standard of care - including adequate surgery - have a substantial risk of relapse ...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006200 Breast cancer stage II PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006202 Breast cancer stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006201 Breast cancer stage III PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10071113 Node-positive breast cancer LLT
    21.1 100000004865 10025025 Lumpectomy (breast cancer) LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073289 Premenopausal breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070575 Estrogen receptor positive breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070577 Oestrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) ES (Completed) AT (Completed) IE (Completed) FR (Completed) GB (GB - no longer in EU/EEA)
    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.
    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-Mon Dec 08 06:26:03 CET 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA