A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination Wit… (NCT07441512) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
26 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must meet the following criteria for study entry:
* 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
* Life expectancy of \> 12 weeks
* Adequate hematologic and organ function within 14 days prior to initiation of study treatment, defined by the following:
* Absolute neutrophil count ≥ 1500/μL
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100,000/μL
* Fasting glucose \< 126 mg/dL or \< 7 mmol/L and glycosylated hemoglobin (HbA1C) \< 6.5% or \< 48 mmol/mol
* Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (\< 3 × ULN if Gilbert's disease)
* Serum albumin ≥ 2.5 g/dL or 25 g/L
* AST and ALT ≤ 2.5 × ULN with the following exception:
* Patients with documented liver metastases: AST and ALT ≤ 5.0 × ULN
o ALP ≤ 2.5 × ULN with the following exception:
* Participants with documented liver or bone metastases: ALP ≤ 5.0 × ULN
o INR \< 1.5 × ULN and aPTT \< 1.5 × ULN
* For participants requiring anticoagulation therapy with warfarin or similar agents (such as Vitamin K antagonists), a stable INR between 2 and 3 is required. If anticoagulation is required for a prosthetic heart valve, then stable INR between 2.5 and 3.5 is permitted.
* Creatinine clearance ≥ 60 mL/min on the basis of the Cockcroft-Gault glomerular …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.