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  • CONTESSA 2

    Acronym: 

    CONTESSA 2

    ACTRN/NCT /ethics: 

    NCT03858972

    Scientific title: 

    Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

    Summary of trial and patient characteristics

    Cancer Type Breast
    Trial Type Treatment
    Phase Phase II Tumour Stream Breast
    Age Range 18 years and older Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2019-02-05
    Molecular Target Anticipated End Date
    Cancer Type Breast
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Breast
    Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Anticipated Start Date 2019-02-05
    Anticipated End Date

    Trial Summary

    CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with taxane-naïve, HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC). The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine, based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). Approximately 125 patients will be enrolled.

    Lay Summary

    Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

    Sponsor / Cooperative group

    Odonate Therapeutics

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Dr Sina Vatandoust Recruiting