SOLAR-1: alpelisib + fulvestrant in advanced breast cancer
Research type
Research Study
Full title
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
IRAS ID
197706
Contact name
Janni Papakrivos
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-000340-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 2 days
Research summary
This study is 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 (AI) treatment. The study will show whether adding alpelisib (PI3K inhibitor) to hormonal therapy, in this case fulvestrant, is more effective treatment for advanced breast cancer than hormonal therapy by itself. The study will include approximately 820 men and postmenopausal women with HR+, HER2-negative advanced breast cancer which progressed on or after aromatase inhibitor treatment.
Patients will undergo molecular assessment of PIK3CA mutation status and after having successfully completed screening procedures, will be assigned to one of the cohorts:
Cohort I; PIK3CA mutant: Patients with a confirmed PIK3CA mutation as per protocol definition
Cohort II; PIK3CA non-mutant: Patients without evidence of PIK3CA mutation as per protocol definition.
Patients will be stratified based on status of lung/liver metastasis and previous treatment with CDK4/6 inhibitors.
Within each cohort patients will be randomly assigned to one of the following treatments: alpelisib plus fulvetstrant or placebo plus fulvestrant.
Patients will receive treatment until disease progression, unacceptable toxicity, death or discontinuation from treatment for any other reason.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0041
Date of REC Opinion
29 Feb 2016
REC opinion
Further Information Favourable Opinion