A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Official Title

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

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

Trial Description

Primary Outcome:

  • Incidence of Grade 3 or higher diarrhea
Secondary Outcome:
  • Incidence of serious adverse events and other adverse events of special interest
  • Incidence and severity of diarrhea
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, 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 (13) 28-day cycles.
  • Loperamide daily for two (2) 28-day cycles and then as needed.
  • Amendment 3, an anti-inflammatory treatment for 1 cycle and loperamide to be administered daily for two (2) 28-day cycles and then as needed. Closed to enrollment.
  • Amendment 4, colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed. Closed to enrollment.
  • Amendment 5, colestipol for 1 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.
  • Amendment 7, 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society