Last updated on April 2018

Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Trastuzumab and Neratinib Followed by Neratinib Monotherapy

Brief description of study

This is a study to evaluate the toxicity profile of neratinib in combination with trastuzumab in patients with early stage breast cancer with the use of anti-diarrheal prophylaxis. The anti-diarrheal medications being tested in this trial are loperamide and crofelemer. Crofelemer is an anti-diarrheal, enteric-coated drug product for oral administration. It is the only botanical drug currently approved by the FDA for oral administration and is approved for the treatment of diarrhea associated with HAART. Crofelemer has a novel mechanism of action, acting directly and simultaneously on 2 distinct intestinal luminal chloride channels. It is an inhibitor of both the cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion (Cl-) channel found on the apical membranes, and the calcium-activated Cl- channels (CaCC) at the luminal membrane of enterocytes. The CFTR Cl-channel and CaCC regulate Cl and fluid secretion by intestinal epithelial cells. Crofelemer acts by blocking Cl- secretion and accompanying high volume water loss in diarrhea, normalizing the flow of Cl- and water in the GI tract.

Detailed Study Description

This is an open-label adjuvant/post neoadjuvant single arm phase 2 trial.

Patients will receive:

Neratinib 240 mg orally once a day for up to 52 weeks while receiving concurrent trastuzumab. After the completion of trastuzumab maintenance therapy (determined by treating physician), neratinib will continue as monotherapy for 12 months. Neratinib is to be taken continuously in 21-day cycles with no rest between cycles unless related to toxicity.

Intensive daily loperamide prophylaxis for the first 2 cycles and then as needed.

Crofelemer 125 mg bid for the first two cycles then as needed.

Each cycle is 21 days. Clinic visits and laboratory studies are planned on day 1 of every cycle for the first 4 cycles, then q4 cycles thereafter. An end of treatment visit will occur 28 days after the last dose of neratinib. Patients who permanently discontinue treatment due to unacceptable toxicity will be followed-up for 28 days after the last dose of neratinib.

Clinical Study Identifier: NCT03094052

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Recruitment Status: Open

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