top of page


The NSABP FB-7 trial

Updated: Aug 13, 2021

Neratinib, trastuzumab, and paclitaxel as neoadjuvant treatment of locally advanced HER2-positive breast cancer

We are very pleased to announce that the results of this international study have just been published in the Breast Cancer Research journal.

This paper publishes one of the MedSIR initial projects, the NSABP FB-7 trial, which stemmed from a fruitful collaboration between MedSIR, NSABP Foundation, and Puma Biotechnology.

The NSABP FB-7 was a multicenter, randomized, phase II trial where a total of 126 HER2-positive patients with locally advanced disease were randomly assigned to neoadjuvant therapy with weekly paclitaxel (P) plus neratinib (N) [Arm 1], P plus trastuzumab (T) [Arm 2] or P plus N+T [Arm 3], followed by doxorubicin and cyclophosphamide with postoperative T.

The primary endpoint was pathologic complete response (pCR), defined as no residual invasive disease in the breast and lymph nodes. Additional endpoints included clinical complete response, pCR in the breast, and rate of adverse events (AEs).

An improvement in the pCR rate was observed in all patients treated with T+N (50%) compared to either the T Arm (38%) or the N Arm (33%). pCR rates in the breast were 50%, 38%, and 52% in Arms 1, 2, and 3, respectively. Clinical assessment in patients with a baseline palpable breast lesion reported an overall complete response in 70% of patients with 66%, 71%, and 74% in Arms 1, 2, and 3, respectively.

Diarrhea was the most frequent AE with grade 3 diarrhea reported in 31% of patients and no grade 4 diarrheal AEs. During the course of the study, a decrease to 21% in grade 3 diarrhea was observed in the N Arms thanks to the introduction of a primary anti-diarrheal prophylaxis.

On behalf of MedSIR, we would like to thank all the patients who have participated in the NSABP FB-7 trial as well as their families and support groups.




bottom of page