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Clinical trials for 2013-001040-62

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    The EU Clinical Trials Register currently displays   44335   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).

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    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
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    Query did not match any studies.
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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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