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Clinical trials for 2013-004172-35

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    The EU Clinical Trials Register currently displays   44334   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: 2013-004172-35. Displaying page 1 of 1.
    EudraCT Number: 2013-004172-35 Sponsor Protocol Number: SB3-G31-BC Start Date*: 2014-02-12
    Sponsor Name:Samsung Bioepis Co., Ltd.
    Full Title: A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Hercep...
    Medical condition: newly diagnosed primary HER2 positive early or locally advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) PL (Completed) BG (Completed) RO (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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