Trial Profile

SOLAR-1: A phase III randomized double-blind, placebo controlled study of alpelisib in combination with fulvestrant for men and postmenopausal women with hormone receptor positive, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 20 Feb 2025

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At a glance

Drugs Alpelisib (Primary) ; Fulvestrant
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Biomarker; Registrational; Therapeutic Use
Acronyms SOLAR; SOLAR-1
Sponsors Novartis; Novartis Pharmaceuticals

17 Nov 2023 Results evaluating the cost-effectiveness of alpelisib plus fulvestrant in patients with PIK3CA-mutated, HR+/HER2- ABC in the USA , by deriving data from SOLAR-1 , published in the Clinical Drug Investigation
28 Jun 2023 Status changed from active, no longer recruiting to completed.
09 May 2023 Planned End Date changed from 8 Jun 2023 to 12 Jun 2023.

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