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July 19, 2011

Genentech Cleopatra Phase III Study Meets Primary Endpoint

Genentech's Cleopatra Phase III study of pertuzumab combined with Herceptin plus docetaxel chemotherapy in patients with HER2-positive metastatic breast cancer has met its primary endpoint. Pertuzumab, a HER2 dimerisation inhibitor, prevents the HER2 receptor from pairing with other HER

By cms admin

Genentech’s Cleopatra Phase III study of pertuzumab combined with Herceptin plus docetaxel chemotherapy in patients with HER2-positive metastatic breast cancer has met its primary endpoint.

Pertuzumab, a HER2 dimerisation inhibitor, prevents the HER2 receptor from pairing with other HER receptors and blocks cell signalling, which may inhibit cancer cell growth.

Herceptin is not a chemotherapy but a targeted medicine, designed to specifically block the HER2 protein on the surface of some cancer cells.

The randomised, double-blind, placebo-controlled two-arm study enrolled 808 people with previously untreated HER2-positive metastatic breast cancer from 19 countries worldwide.

The primary study endpoint was progression-free survival as assessed by an independent review.

Secondary endpoints are overall survival, safety profile, overall response rate, duration of remission, quality of life and correlation of biomarkers with clinical outcomes.

The study showed that pertuzumab combined with Herceptin (trastuzumab) and docetaxel chemotherapy improved progression-free survival rate compared to Herceptin and docetaxel in people with metastatic breast cancer.

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