Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Amy Chien

Description

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.

Details

This is an open-label, Phase 2 study that will investigate the incidence and severity of diarrhea in early-stage HER2+ breast cancer patients receiving neratinib with loperamide, alone and in combination with an anti-inflammatory treatment or a bile acid sequestrant treatment, or neratinib dose escalation, who have previously undergone a course of trastuzumab therapy in the adjuvant setting.

Patients will receive:

  • Neratinib 240 mg orally once daily with food for thirteen 28-day cycles.
  • Loperamide daily for two 28-day cycles and then as needed.
  • Amendment 3, an anti-inflammatory treatment for one cycle and loperamide to be administered daily for two 28-day cycles and then as needed. Closed to enrollment.
  • Amendment 4, colestipol for one cycle and loperamide to be administered one cycle and then as needed. Closed to enrollment.
  • Amendment 5, colestipol for one cycle and loperamide as needed. Closed to enrollment.
  • Amendment 6/6.1, 120 mg neratinib for Week 1 (C1D1-C1D7), followed by 160 mg neratinib for Week 2 (C1D8-C1D14), followed by 240 mg neratinib for Week 3 and thereafter (C1D15 to end of treatment). Loperamide as needed. Closed to enrollment.
  • Amendment 7/7.1, 160 mg neratinib for the first 2 weeks (C1D1 - C1D14), followed by 200 mg neratinib for the next 2 weeks (C1D15 - C1D28), followed by 240 mg neratinib thereafter (C2D1 to end of treatment). Loperamide as needed.

Keywords

Early Stage HER2+ Breast Cancer HER2 + Breast Cancer Neratinib Nerlynx Loperamide Colestipol Budesonide Breast Neoplasms Diarrhea Antidiarrheals Budesonide and Loperamide Colestipol and Loperamide Neratinib Dose Escalation 1 Neratinib Dose Escalation 2

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • St. Jude Hospital Yorba Linda DBA Saint Joseph Heritage Healthcare withdrawn
    Santa Rosa California 95403 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Puma Biotechnology, Inc.
ID
NCT02400476
Phase
Phase 2
Study Type
Interventional
Last Updated