publication date: Oct. 1, 2014

Final Results from CLEOPATRA Phase III Trial Show Perjeta Increased OS 15.7 Months


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Final phase III trial results showed that adding Perjeta to Herceptin and docetaxel chemotherapy increased overall survival to over four-and-a-half years in patients with previously untreated HER2-positive metastatic breast cancer.

Data from the CLEOPATRA study showed that the addition of Perjeta (pertuzumab) increased median overall survival 15.7 months compared to Herceptin (trastuzumab) and docetaxel alone—to 56.5 and 40.8 months, respectively.

The data were presented at the Presidential Symposium at the European Society for Medical Oncology Congress in Madrid.

“Adding Perjeta to treatment with Herceptin and chemotherapy resulted in the longest survival observed to date in a clinical study of people with HER2-positive metastatic breast cancer,” said Sandra Horning, chief medical officer and head of Global Product Development at Genentech, Perjeta’s sponsor.

Perjeta in combination with Herceptin and docetaxel chemotherapy is approved in the U.S. and the European Union for people with previously untreated HER2-positive metastatic breast cancer.

CLEOPATRA was an international, randomized, double-blind, placebo-controlled study. The study evaluated 808 patients with previously untreated HER2-positive MBC, or with HER2-positive MBC that had come back after prior therapy in the adjuvant or neoadjuvant setting. The primary endpoint of the study was progression-free survival.

An interim OS analysis was previously presented at the San Antonio Breast Cancer Symposium in 2012. At the time of the analysis, median OS had not yet been reached for people receiving the Perjeta regimen as more than half of these people continued to survive.

The results presented at the ESMO Congress are from the final pre-specified OS … Continue reading CCL Sept – Breast Cancer

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