Clinical Trial

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

Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07441512
Lead Sponsor Hu Hai
Collaborators: Zhejiang Cancer Hospital
Conditions TNBC - Triple-Negative Breast Cancer, TNBC
Enrollment 26 participants
Start Date 2026-03-15
Primary Completion 2028-03-15 (estimated)
Study Completion 2028-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-02