Formal discussant of the ado-trastuzumab emtansine plus pertuzumab trial, Mark Pegram, MD, Director of the Breast Cancer Program at Stanford Women’s Cancer Center and Co-Director of Stanford’s Molecular Therapeutics Program, Stanford, California, said that I-SPY 2 has several strengths. They include a strong scientific rationale for the combination, the innovative study design, the inclusion of anthracycline exposure preoperatively, and the inclusion of pathologic complete response data on subsets of HER2-positive patients relative to hormone receptor status, he noted.

“The combination regimen was safe and relatively well tolerated, and the cardiac safety from a prior phase III metastatic trial of the combination was impressive,” Dr. Pegram said.

Commendable Design

This study cannot change clinical practice tomorrow, but it is an interesting, efficient, and extremely elegant way to study new drugs.

— Martine Piccart, MD, PhD

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Martine Piccart, MD, PhD, Professor of Oncology, Université Libre de Bruxelles, and Director of Medicine, Jules Bordet Institute, Brussels, commended the I-SPY 2 investigators for the innovative design of their study and the efficient method of prioritizing regimens for further study.

“This study cannot change clinical practice tomorrow, but it is an interesting, efficient, and extremely elegant way to study new drugs,” she commented

Dr. Piccart noted that the control arm of I-SPY 2 is suboptimal. “We think the new standard of care will be a taxane plus trastuzumab and pertuzumab. CLEOPATRA showed a huge effect for this combination in metastatic breast cancer, and if the ­APHINITY trial is positive, this will be the new standard of care.”

APHINITY is an ongoing trial with more than 4,500 patients with operable HER2-positive breast cancer randomized to pertuzumab, chemotherapy, and trastuzumab vs chemotherapy, trastuzumab, and placebo. ■

Disclosure: Dr. Piccart has received honoraria from Roche. Dr. Pegram reported no potential conflicts of interest.