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.
Signed Informed Consent Form
Female participants who are at least 18 years of age on the day of signing informed consent
Evaluable or measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Pregnancy, lactation, or intention to become pregnant during the study
Metaplastic breast cancer
Radiotherapy within 4 weeks before Cycle 1 Day 1
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Single group
Inavolisib in Combination With Eribulin
DrugAll 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.
ORR by Investigator assessment per RECIST 1.1
ORR by Investigator assessment per RECIST 1.1
Incidence and severity of adverse events (graded by CTCAE v5.0)
Number of participants with Abnormal and clinically significant change from baseline in targeted vital signs
Number of participants with Abnormal and clinical significant change from baseline in targeted clinical laboratory test results
Secondary Outcome Measure
The total cumulative dose of Inavolisib actually administered to each subject (unit: mg), calculated by summarizing the daily dosing records documented in the electronic data system or source documents.
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