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

• Status: Completed
• Trial end date: 2021-04-22
• Target enrollment: 0
• Participant gender: All

Summary

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 or other prophylactic measures.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Puma Biotechnology, Inc.
• Treatments: Antidiarrheals; Budesonide; Colestipol; Loperamide

Criteria

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