NCT05392608

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast): A Phase 2 Study on Fulvestrant Beyond Progression in Combination With Alpelisib for PIK3CA-mutated, Hormone-receptor Positive HER2 Negative Advanced Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Borstkanker Onderzoek Groep · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates 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.

Conditions

• Neoplasm, Breast
• Congenital, Familial and Genetic Disorders

Interventions

Type	Name	Description
DRUG	Alpelisib 150 MG Oral Tablet [Piqray]	Alpelisib 300mg once daily (may be reduced to 1dd250 or 1dd200mg in case of toxicity)
DRUG	Fulvestrant	Fulvestrant 300mg 1x/four weeks

Timeline

• Start date: 2022-06-02
• Primary completion: 2026-01-01
• Completion: 2028-03-01
• First posted: 2022-05-26
• Last updated: 2025-09-17

Locations

25 sites across 1 country: Netherlands