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

This is an open-label, Phase 2 study that will investigate the incidence of diarrhea in HER2+ breast cancer patients receiving neratinib with intensive high dose loperamide diarrhea prophylaxis who have previously undergone a course of trastuzumab therapy in the adjuvant setting.

Inclusion Criteria:

* Histologically confirmed stage 1 through stage 3c primary adenocarcinoma of the breast.

* Documented HER2 overexpression or gene-amplified tumor by a validated, approved method.

* Patients must have completed a course of prior adjuvant trastuzumab or experienced side effects that resulted in early discontinuation of trastuzumab that have since resolved.

* The last dose of trastuzumab must have been given >2 weeks and ≤1 year (365 days) from enrollment.
Phase II
Cancer, All Other
Alison Conlin, M.D.
Puma Biotechnology
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Newberg
  • Oncology and Hematology Care Southeast
  • Oncology and Hematology Care Westside