NSABP FB-7: Neoadjuvant therapy with neratinib plus trastuzumab in locally advanced HER2-positive breast cancer
Update: 2016-04-28
Description
Dr Jacobs talks to ecancertv at SABCS 2015 about the phase II NSABP FB-7 trial that evaluated the efficacy and safety of neoadjuvant therapy with weekly paclitaxel plus neratinib, trastuzumab or both for 12 weeks followed by standard chemotherapy before surgery in women with locally advanced HER2-positive breast cancer.
The underlying premise for the trial was that combining the investigational agent neratinib and trastuzumab may be better than trastuzumab alone as both agents target HER2 by different mechanisms.
The trial involved 126 women and the primary endpoint of pathological complete response rate (pCR). Dr Jacobs reports that in women who were hormone-receptor (HR)-positive the pCR for the neratinib, trastuzumab or the combination were similar. However, in women who were HR-negative the pCR was higher when the combination was used.
Dr Jacobs observes that intensive anti-diarrhoeal prophylaxis was able to negate the effects of neratinib on the gastrointestinal tract and that the side effect of diarrhea was most common in the first cycle of treatment but could be managed well thereafter.
The underlying premise for the trial was that combining the investigational agent neratinib and trastuzumab may be better than trastuzumab alone as both agents target HER2 by different mechanisms.
The trial involved 126 women and the primary endpoint of pathological complete response rate (pCR). Dr Jacobs reports that in women who were hormone-receptor (HR)-positive the pCR for the neratinib, trastuzumab or the combination were similar. However, in women who were HR-negative the pCR was higher when the combination was used.
Dr Jacobs observes that intensive anti-diarrhoeal prophylaxis was able to negate the effects of neratinib on the gastrointestinal tract and that the side effect of diarrhea was most common in the first cycle of treatment but could be managed well thereafter.
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