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Dr. Sandra M. Swain  

Medical Director, Washington Cancer Institute at MedStar Washington Hospital Center

Swain: The CLEOPATRA trial was a prospective, phase III, randomized study in patients who had not received any chemotherapy for metastatic HER2-positive breast cancer. The study included 808 patients and they were randomized to either receive placebo plus trastuzumab plus docetaxel [control group] or pertuzumab plus trastuzumab plus docetaxel [pertuzumab group]. It was firstline treatment, and the endpoint of the study was to look at an independently assessed progression-free survival. It really had a spectacular result in my opinion. It was a progression-free survival advantage of 6 months. This was actually a placebo-controlled study, so even though progression-free survival can be a difficult endpoint, it was clear in this study that there really was a benefit to the addition of the drug pertuzumab. The interim analysis of survival showed a trend in favor of pertuzumab in the initial report that we released at the San Antonio Breast Cancer Symposium and published in The New England Journal of Medicine in December 2011, but most recently we’ve reanalyzed the survival and, actually, a press release came out this past June showing that there was a survival benefit also with the addition of pertuzumab. - See more at: http://www.onclive.com/publications/oncology-business-news/2012/November-2012/Treatment-and-Cost-Implications-of-Pertuzumab#sthash.vnk7bBp5.dpuf

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