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A randomised, multicentre, multinational Phase II study to evaluate pertuzumab in combination with trastuzumab given either concomitantly or sequentially with standard anthracycline based chemotherapy...

Update Il y a 4 ans
Reference: EUCTR2009-012019-17

A randomised, multicentre, multinational Phase II study to evaluate pertuzumab in combination with trastuzumab given either concomitantly or sequentially with standard anthracycline based chemotherapy or concomitantly with a non-anthracycline based chemotherapy regimen, as neoadjuvant therapy for patients with locally advanced, inflammatory or early stage HER2-positive breast cancer

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Extract

To make a preliminary assessment of the tolerability of neoadjuvant treatment with one of the following treatment regimens: Arm A FEC->T with trastuzumab and pertuzumab given from the start of the chemotherapy regimen (i.e. concurrently with the anthracycline) OR Arm B FEC->T with trastuzumab and pertuzumab given from the start of the taxane treatment (i.e. following the anthracycline) OR Arm C TCH with pertuzumab, with both antibodies being given from the start of the chemotherapy. The primary objective will be evaluated when all patients have received six cycles of neoadjuvant treatment, had their surgery and all necessary samples taken or withdrawn from the study whichever is earlier.

Inclusion criteria

  • Locally advanced, inflammatory or early stage HER2 positive breast cancer

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