José Baselga, MD, PhD, a professor in the Department of Medicine at Harvard Medical School and chief of Hematology/Oncology at Massachusetts General Hospital, describes the CLEOPATRA trial that examined the addition of pertuzumab for the first-line treatment of women with HER2-positive metastatic breast cancer.

CLEOPATRA was a randomized, phase III, placebo controlled trial with the primary endpoint of progression-free survival. The trial randomly combined placebo or pertuzumab with trastuzumab (Herceptin) and docetaxel. The control arm experienced disease progression at 12.4 months while the experimental arm did not progress until 18.5 months (HR = 0.62; P= <0.0001).

The results of the trial were positive and although the survival data has not fully matured yet an interim analysis did show a very strong trend towards an overall survival benefit. The addition of pertuzumab entailed few additional side effects but did result in higher rates of diarrhea and neutropenia.

Baselga defines the trial as being a very positive first-line study for HER2 disease that is likely to become the standard of therapy for this patient population in the future.


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