SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
Status:
Not yet recruiting
Trial end date:
2028-03-01
Target enrollment:
Participant gender:
Summary
The study is a nationwide, multicenter single-arm phase 2 study. In the current phase 2 study
we will investigate the efficacy of the combination of fulvestrant and alpelisib directly
after progression on fulvestrant (either in first or second line, with or without previous
use of CDK4/6-inhibitor) in patients with HR+ HER2- advanced breast cancer with PIK3CA
mutated tumors.
All eligible patients must have progressive disease on fulvestrant as latest treatment line.
Previous treatment with a CDK4/6 inhibitor in first or second line is obligatory. After
progressive disease is confirmed, it is important to continue fulvestrant (without CDK4/6
inhibition) during the screening period awaiting study enrollment.
After study enrollment all participants will be treated with alpelisib and fulvestrant beyond
progression. Follow-up time will be until progression or death or until a different oncolytic
treatment has started (in case no progressive disease during previous fulvestrant and
alpelisib treatment has been documented).
Should participants discontinue due to reasons other than progression or death (e.g.
toxicity), then they should still be evaluated for disease progression every 8 weeks as per
protocol until progression, unless they do not wish to proceed with these screenings, or
receive a different oncolytic treatment.