ARTICLE | Clinical News

Pertuzumab: Phase II data

December 13, 2010 8:00 AM UTC

The international Phase II NEOSPHERE trial in 417 women with early-stage, HER2-positive breast cancer showed that neoadjuvant therapy prior to surgery with pertuzumab plus Herceptin trastuzumab and Taxotere docetaxel met the primary endpoint of significantly improving pCR rate compared to Herceptin plus Taxotere (45.8% vs. 29%, p=0.014). The triple combination therapy also significantly improved pCR rates compared to pertuzumab plus Herceptin (16.8%) and compared to pertuzumab plus Taxotere (24%, p=0.003). The most common >=grade 3 adverse events were neutropenia, fever that was associated with neutropenia and diarrhea, and there was no significant increase in side effects or cardiac risk for the triple combination therapy compared to Herceptin plus Taxotere. The trial enrolled women with newly-diagnosed HER2-positive early, inflammatory or locally advanced breast cancer not previously treated with Herceptin. Data were presented at the San Antonio Breast Cancer Symposium. ...