An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis.

Investigator: Jo Chien, MD

Location(s): United States


In a recent Phase 3 study conducted in women with early stage HER2-positive breast cancer who had previously received adjuvant treatment with trastuzumab, neratinib demonstrated a 33% improvement in disease-free survival versus placebo (hazard ratio = 0.67, which was statistically significant with a p-value of 0.0046). The rationale of this study is to collect safety data in patients with early-stage HER2-positive breast cancer who have completed a prior course of adjuvant trastuzumab in order to expand the safety profile of neratinib when given concomitantly with intensive antidiarrheal prophylaxis for 2 cycles. The results will guide how to better manage neratinib-related diarrhea in this patient population.
The primary objective of this study is to characterize the incidence and severity of diarrhea in patients with early-stage HER2 overexpressed/amplified (HER2+) breast cancer treated with neratinib when administered with intensive loperamide prophylaxis, after prior treatment with trastuzumab. The secondary objectives of this study are:
1 To evaluate the association between loperamide exposure and incidence and severity of diarrhea.
2 To assess incidence of serious adverse events and other adverse events of special interest.