A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA (BCT 1901 CAPTURE)

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THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 66 participants with oestrogen receptor positive, HER2 negative advanced breast cancer and PIK3CA mutant circulating DNA who are randomised to evaluate treatment with alpelisib plus fulvestrant compared with capecitabine on progression free survival. The experimental arm is alpelisib at a dose of 300 mg administered by oral tablet once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in combination with fulvestrant 500 mg intramuscular every 28 days. The comparator arm is capecitabine at a dose of 1000 mg/m^2 administered by oral tablet twice daily on Day 1 to 14 of a 21 day cycle. the primary endpoint is progression free survival (PFS) measured as per RECIST 1.1. Cancer Australia demographic data has been collected including: Age, Postcode of usual residence, Race/Ethnicity, CALD status (Country of Birth, Main language other than English used as the principle means of communication).

Notes

HeSANDA 1.0.0