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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).

Acronym:

CONTESSA 2

ACTRN/NCT /ethics:

NCT03858972

Scientific title:

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

Sponsor / Cooperative group:

Odonate Therapeutics

Trial & Patient Characteristics

Cancer TypeBreast
Trial TypeTreatment
PhasePhase II
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2019-02-05
Anticipated End Date-

Participating Hospitals

HospitalFlinders Medical Centre
Clinical Trial CoordinatorAlex Scott-Hoy
Emailalex.scott-hoy@sa.gov.au
Phone08 8204 4830
Principal InvestigatorDr Sina Vatandoust
Recruitment StatusRecruiting