An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Intensive Loperamide Prophylaxis
An open-label, Phase 2 study that will investigate the incidence of diarrhea in HER2+ breast cancer patients receiving neratinib with intensive loperamide diarrhea prophylaxis, alone and in combination with anti-inflammatory treatment, who have previously undergone a course of trastuzumab therapy in the adjuvant setting
Patients will receive:
Early Stage HER2+ Breast Cancer HER2 + Breast Cancer Neratinib Budesonide Mesalamine Colestipol Bismuth subsalicylate Loperamide Antidiarrheals Bismuth
Open to people ages 18 years and up
Clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry, including
Screening laboratory assessments outside the following limits:
Absolute neutrophil count (ANC) <1,000/μl (<1.0 x 109/L) Platelet count <100,000/μl(<100 x 109/L) Hemoglobin <9 g/dL Total bilirubin>1.5 x institutional upper limit of normal (ULN) (i n case of known Gilbert's syndrome, <2 x ULN is allowed) Creatinine Creatinine clearance <30 mL/min (as calculated by Cockcroft-Gault formula or Modification of Diet in Renal Disease [MDRD] formula)
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02400476.
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