Summary

for people ages 18 years and up (full criteria)
at UCLA UCSF
study started
estimated completion

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

  • Ronald Reagan UCLA Medical Center in progress, not accepting new patients
    Los Angeles California 90095 United States
  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • The Oncology Institute of Hope and Innovation in progress, not accepting new patients
    Santa Ana California 92705 United States
  • East Valley Hematology Oncology Medical Group withdrawn
    Burbank California 91505 United States

Details

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