Phase 3 Study of Pertuzumab for HER2+ Metastatic Breast Cancer

Roche announced positive results from the Phase 3 CLEOPATRA study evaluating pertuzumab for the treatment of HER2+ metastatic breast cancer. The randomized, double-blind, placebo-controlled study compared the combination of pertuzumab, Herceptin (trastuzumab; Genentech), and Taxotere (docetaxel; Sanofi Aventis) chemotherapy to trastuzumab and docetaxel alone in patients with previously untreated HER2+ metastatic breast cancer. People who received pertuzumab in combination with trastuzumab and chemotherapy experienced a 38% reduction in the risk of their disease worsening or death (progression-free survival, or PFS), (HR=0.62; P<0.0001). The median PFS improved by 6.1 months from 12.4 months for trastuzumab and chemotherapy to 18.5 months for pertuzumab, Herceptin and chemotherapy. Overall survival data are currently immature, with a trend in favor of the pertuzumab combination.

Pertuzumab is a humanized monoclonal antibody being studied in early and advanced stages of HER2+ breast cancer and advanced HER2+ gastric cancer. Pertuzumab is designed specifically to prevent the HER2 receptor from pairing with other HER receptors (EGFR/HER1, HER3 and HER4), a process that is believed to play an important role in the growth and formation of several different cancer types. By preventing receptor pairing, pertuzumab is thought to block cell signaling, which may inhibit cancer-cell growth or lead to the death of the cancer cell. Binding of pertuzumab to HER2 may also signal the body's immune system to destroy the cancer cells.

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