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JCO Early Release, published online ahead of print Feb 1 2010
Received May 20, 2009 Phase II Trial of Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer That Progressed During Prior Trastuzumab Therapy
From the Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain; British Columbia Cancer Agency, Vancouver, British Columbia; Ottawa Regional Cancer Center, Ottawa, Ontario, Canada; The Christie, Manchester; Mount Vernon Cancer Centre, Middlesex; Roche Products Limited, Welwyn, United Kingdom; Divisione di Oncologia Medica, University Hospital, Modena; Oncologia Medica, Milan, Italy; and Centre Georges-François-Leclerc, Dijon, France. * To whom correspondence should be addressed. E-mail: jbaselga{at}vhebron.net
Purpose: Pertuzumab, a human epidermal growth factor receptor 2 (HER2) –targeted monoclonal antibody, potently inhibits HER2 dimerization and HER-mediated signaling pathways. Pertuzumab and the approved HER2-targeted monoclonal antibody trastuzumab have complementary mechanisms of action and result in enhanced antitumor activity when combined. This phase II trial assessed the efficacy and safety profile of the combination in patients with HER2-positive breast cancer whose disease had progressed during prior trastuzumab-based therapy. Patients and Methods: This was a multicenter, open-label, single-arm, Simon two-stage study. Patients with advanced HER2-positive breast cancer in whom disease progression had occurred during prior trastuzumab-based therapy received trastuzumab weekly (4 mg/kg loading dose, then 2 mg/kg every week) or every 3 weeks (8 mg/kg loading dose, then 6 mg/kg every 3 weeks) and pertuzumab every 3 weeks (840 mg loading dose, then 420 mg every 3 weeks). Treatment continued until disease progression or excessive toxicity. Results: All 66 patients were assessable for efficacy and safety. The objective response rate was 24.2%, and the clinical benefit rate was 50%. Five patients (7.6%) experienced a complete response, 11 patients (16.7%) experienced a partial response, and 17 patients (25.8%) experienced stable disease of Conclusion: The combination of pertuzumab and trastuzumab is active and well tolerated in patients with metastatic HER2-positive breast cancer who had experienced progression during prior trastuzumab therapy.
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Copyright © 2010 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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6 months. Median progression-free survival was 5.5 months. Overall, the combination of pertuzumab and trastuzumab was well tolerated, and adverse events were mild to moderate. Cardiac dysfunction was minimal, and no patients withdrew as a result of cardiac-related adverse events.
