NCT04762979

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Marina N Sharifi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility. All patients must have HER2 negative breast cancer with the identified PIK3CA mutation and received at least one line of endocrine therapy. The study will consist of a screening phase, a treatment phase, and a post-treatment phase which includes safety, efficacy, and follow-up. The treatment phase will include taking alpelisib daily in combination with continued use of either Fulvestrant or Aromatase Inhibitor per standard of care until disease progression or unacceptable toxicity.

Conditions

• Hormone Receptor Positive Breast Carcinoma
• HER2-negative Breast Cancer
• PIK3CA Mutant Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Alpelisib	Alpelisib 300mg, PO, days 1-28 of each cycle.
DRUG	Fulvestrant	Fulvestrant 500mg, IM, once monthly
DRUG	Aromatase inhibitor	Aromatase Inhibitor, administered per standard of care

Timeline

• Start date: 2021-02-12
• Primary completion: 2025-10-23
• Completion: 2026-05-01
• First posted: 2021-02-21
• Last updated: 2026-01-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study