Last updated on November 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early Stage HER2+ Breast Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 18; male or female
  • Early breast cancer (stage I-3c)
  • Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+
  • Prior course of adjuvant trastuzumab given >2 weeks and 1 year from enrollment
  • No evidence of local/regional recurrence or metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Male patients with female partners of childbearing potential must agree and commit to use a condom and women of childbearing potential must not be pregnant and must agree and commit to the use of a highly effective non-hormonal method of contraception
  • Left ventricular ejection fraction (LVEF) 50% measured by multiple-gated acquisition scan (MUGA) or ECHO

Exclusion Criteria:

  • Major surgery < 30 days
  • Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) < 14 days
  • Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active cardiac disease
  • Significant chronic GI disorder with diarrhea as a major symptom
  • Active, unresolved infections
  • Currently pregnant or breast-feeding

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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