Trials / Completed

CompletedNCT03094052

Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib

An Open Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With HER2+ Breast Cancer Treated With Neratinib With or Without Trastuzumab

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 11 (actual)

Sponsor: University of California, San Francisco · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies the incidence and severity of diarrhea in patients with stage II-IIIC HER2 Positive breast cancer treated with trastuzumab and neratinib. Trastuzumab is a form of targeted therapy because it attaches itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and neratinib may work better in treating patients with stage II-IIIC HER2 positive breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To characterize the incidence and severity of diarrhea in patients with early stage breast cancer receiving adjuvant neratinib with or without trastuzumab in the setting of anti-diarrheal strategies. SECONDARY OBJECTIVES: I. To evaluate the incidence of grade 3 or higher diarrhea using the dose-escalation strategy and anti-diarrhea medications as needed (prn) in patients who received prior trastuzumab emtansine (T-DM1). II. To assess neratinib adherence, holds, delays, and early discontinuation throughout the course of study therapy which includes patients receiving neratinib for \> 1 year. III. To assess overall toxicity including constipation and cardiac toxicity with concomitant neratinib and trastuzumab. OUTLINE: This is a dose-escalation study of neratinib. Patients receive one of the following treatment regimen: NERATINIB MONOTHERAPY: Patients receive neratinib orally (PO) once daily (QD) on days 1-21. Cycles repeats every 21 days for up to 55 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive loperamide and/or diphenoxylate hydrochloride/atropine sulfate as needed per physician discretion for symptom management. NERATINIB AND TRASTUZUMAB: Patients receive neratinib PO QD on days 1-21. Patients also receive trastuzumab maintenance therapy as determined by treating physician. Treatment repeats every 21 days for up to 55 weeks in the absence of disease progression or unacceptable toxicity. After completion of trastuzumab treatment, patients may continue on neratinib monotherapy for the remainder of the 55 weeks. Patients may receive loperamide and/or diphenoxylate hydrochloride/atropine sulfate as needed per physician discretion for symptom management. After completion of studies treatment, patients are followed up for 28 days.

Conditions

Interventions

Type	Name	Description
DRUG	Neratinib	Given orally (PO)
BIOLOGICAL	Trastuzumab	Given Intravenously (IV)
DRUG	Loperamide	Given PO
DRUG	Crofelemer	Given PO
DRUG	Diphenoxylate/Atropine	Allowed for participants experiencing refractory diarrhea

Timeline

Start date: 2018-10-09
Primary completion: 2022-10-31
Completion: 2022-10-31
First posted: 2017-03-29
Last updated: 2025-06-26
Results posted: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT03094052. Inclusion in this directory is not an endorsement.