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Clinical trial

ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR Positive, HER2-negative, Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment.

NCT05631795 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.

NCT NCT05631795
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Registry record

As filed in ClinicalTrials.gov.

Title
ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR Positive, HER2-negative, Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment.
Lead sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Overall status
Completed
Start date
August 9, 2022
Completion date
June 12, 2025
Enrollment
40 (actual)
Sites
12

Conditions

As the registry lists them; a condition with its own page is linked.

advanced breast cancer