NCT07441512

A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Hu Hai · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Simon's optimal two-stage design, single-arm, Phase II study with first 6 patients in the safety run-in portion. PIK3CAmut advanced triple-negative breast cancer(TNBC) patients who have progressed on at least one prior line of systemic therapy in advanced setting will be enrolled to receive inavolisib plus eribulin treatment. The study is carried out in two stages. In Stage One, 10 patients are accrued. If there are 4 or more responses among these 10 patients and positive recommendation by the safety review meeting based on the evaluation of first 6 safety run-in patients' data, additional 16 patients will be accrued in Stage Two, resulting in a total patient number of 26. Otherwise, the study will be terminated and a report will be prepared outlining the observed data and the rationale for termination.

Conditions

• TNBC - Triple-Negative Breast Cancer
• TNBC

Interventions

Type	Name	Description
DRUG	Inavolisib in Combination With Eribulin	All enrolled patients will receive inavolisib 9 mg once daily (QD) with eribulin (1.4 mg/m2 IV days 1 and 8), both administered every 21 days until RECIST 1.1-defined progression or another discontinuation criterion is met. Following treatment discontinuation, choice of subsequent therapy will be at the discretion of the Investigator.

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-03-15
• Completion: 2028-03-15
• First posted: 2026-03-02
• Last updated: 2026-03-02