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Trial Summary

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.



ACTRN/NCT /ethics:


Scientific 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 intensive Loperamide prophylaxis.

Sponsor / Cooperative group:

Puma Biotechnology/ Novoteh

Trial & Patient Characteristics

Cancer TypeBreast
Trial TypeTreatment
PhasePhase II
Age Range18 years and older
Tumour Stream Breast cancer
Cancer StageEarly\In Situ
Anticipated Start Date2015-02-01
Anticipated End Date2019-04-01

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Phone08 8292 2240
Principal InvestigatorDr Kerry Cheong
Recruitment StatusRecruitment on Hold