Editor’s Note: The first paragraph of a previous version of this article used the phrase “clinical stage II or II breast cancer.” This has been changed to “clinical stage II or III.”

Veliparib and carboplatin may together be an effective treatment for patients with clinical stage II or III breast cancer, according to an article published recently in the New England Journal of Medicine.1

The Investigation of Serial Studies to Predict Your Therapeutic Response through Imaging and Molecular Analysis 2 (I-SPY 2) is a multicenter, randomized, phase 2 trial in which investigators contrast experimental regimens against controls for the treatment of breast cancer, which is difficult to treat with targeted therapies, due to the heterogeneousness of the disease.

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Seventy-two patients were assigned to receive veliparib, an oral therapy that preclinical models have shown to potentiate the antineoplastic effect of carboplatin, in conjunction with carboplatin. Forty-four patients were assigned to control therapy.

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Among patients with triple-negative breast cancer, the pathological complete response rate was 51% for the experimental regimen, in contrast with 26% for patients in the control group. Grade 3 to 4 adverse events were, however, far more common in the veliparib-carboplatin group, with 71% versus 0% of patients in the control group experiencing neutropenia, 21% versus 0% experiencing thrombocytopenia, and 28% versus 0% experiencing anemia.

The authors conclude that the experimental regimen has an 88% probability of success in a phase 3 trial.


  1. Rugo HS, Olopade OI, DeMichele A, et al. Adaptive randomization of veliparib–carboplatin treatment in breast cancer. N Engl J Med. 7 Jul 2016. doi: 10.1056/NEJMoa1513749 [Epub ahead of print]