|Phase II||Treatment||Closed||18 and over||Pharmaceutical / Industry||WO20697|
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- female patients, >=18 years of age;
- locally advanced, inflammatory or early stage invasive breast cancer;
- HER2 positive (HER2+++ by IHC or FISH/CISH+).
- metastatic disease (Stage IV) or bilateral breast cancer;
- previous anticancer therapy or radiotherapy for any malignancy;
- other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
- insulin-dependent diabetes;
- clinically relevant cardiovascular disease.
Trial Lead Organizations/Sponsors
F. Hoffmann - La Roche, Limited
|Clinical Trials||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00545688
ClinicalTrials.gov processed this data on March 03, 2014
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