Meredith Buxton on I-SPY 2 Trial for HER2+ Breast Cancer

Meredith Buxton, PhD, research director, assistant professor, University of California, San Francisco School of Medicine, discusses the I-SPY 2 trial for patients with HER2-positive breast cancer.

I-SPY 2 is a standing trial platform that is evaluating several investigational agents across multiple tumor types. This is to rapidly screen such drugs and their potential benefit in patients prior to moving them to phase III studies. The HER2-positive breast cancer cohort examined neoadjuvant ado-trastuzumab emtansine (T-DM1; Kadcyla) in combination with pertuzumab (Perjeta), which was shown to improve pathologic complete response compared with the standard of care of paclitaxel (Abraxane) combined with trastuzumab (Herceptin).

The T-DM1/pertuzumab findings demonstrated this combination's efficacy in HER2-positive patients, Buxton explains. Because pertuzumab received accelerated FDA approval in 2013, these results confirm the efficacy of the agent. With regard to T-DM1, these data confirm the agent’s tolerable safety profile and that it can be combined with pertuzumab. A phase III study will need to be conducted.