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  • PUMA-NER-6201

    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

    Summary of trial and patient characteristics

    Cancer Type Breast
    Trial Type Treatment
    Phase Tumour Stream HER positive Breast
    Age Range 18 years and older Cancer Stage In Situ
    Sex Both Anticipated Start Date 2015-02-01
    Molecular Target TBA Anticipated End Date 2019-04-01
    Cancer Type Breast
    Trial Type Treatment
    Phase
    Age Range 18 years and older
    Sex Both
    Molecular Target TBA
    Tumour Stream HER positive Breast
    Cancer Stage In Situ
    Anticipated Start Date 2015-02-01
    Anticipated End Date 2019-04-01

    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, who have previously undergone a course of trastuzumab therapy in the adjuvant setting

    Lay Summary

    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

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Helen Daykin hdaykin@adelaidecancercentre.com.au 08 8292 2240 Recruiting
    Calvary North Adelaide Hospital