Skip to content

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.

Acronym:

PUMA-NER-6201

ACTRN/NCT /ethics:

NCT02400476

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
SexBoth
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
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Kerry Cheong
Recruitment StatusRecruitment on Hold