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Trial Summary

This study aims to find out whether treatment with alpelisib plus fulvestrant increases progression-free survival compared to capecitabine in women and men with eostrogen receptor positive (ER+), HER2-negative advanced breast cancer who have a PIKC3A mutation identified in circulating tumour DNA (ctDNA).

Acronym:

CAPTURE

ACTRN/NCT /ethics:

ACTRN12619001117101

Scientific title:

BCT 1901 (CAPTURE): Women or men with oestrogen receptor positive, HER2 negative advanced breast cancer and PIK3CA mutant circulating DNA will be randomised to evaluate treatment with alpelisib plus fulvestrant compared with capecitabine on progression free survival.

Trial & Patient Characteristics

Cancer TypeBreast
Trial TypeTreatment
PhasePhase II
Age Range18+ years
SexBoth
Tumour StreamBreast
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2020-03-01
Anticipated End Date-

Participating Hospitals

HospitalThe Queen Elizabeth Hospital
Clinical Trial CoordinatorPamela Cooper
Emailpamela.cooper@sa.gov.au
Phone08 8222 6410
Principal InvestigatorDr Amanda Townsend
Recruitment StatusRecruiting