A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib… (NCT05646862) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
United States, Argentina, Australia420 participantsStarted 2023-06-07
Plain-language summary
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.
Enrollment for the main study is now complete.
Who can participate
Age range
18 Years
Sex
ALL
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 for Main Study and Sub-study:
* If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1
* Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
* Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test
* Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 2 prior lines of systemic therapy in mBC setting; CDK4/6i based therapy does not need to be the last one received prior study entry; one line of chemotherapy in mBC setting allowed
* Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
* Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
* Life expectancy of \> 6 months
* Adequate hematologic and organ function prior to initiation of study treatment
Exclusion Criteria for both Main Study and Sub-study:
* Metaplasti…
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.
1This trial is comparing inavolisib plus fulvestrant against alpelisib plus fulvestrant — both are PIK3CA-targeting combinations — so how do the known side effect profiles of these two drugs differ, and does one seem better suited to my specific health situation?
2Since this is a Phase 3 trial and recruitment is no longer active, what does the current evidence suggest about how inavolisib compares to alpelisib in terms of safety and how well it controls disease progression in someone like me?
3My tumor has a PIK3CA mutation and I've already been treated with a CDK4/6 inhibitor plus endocrine therapy — given that background, would you expect either arm of this trial to offer an advantage over other available second-line options I might qualify for?
4The trial includes a sub-study measuring how inavolisib affects the blood levels of other drugs like midazolam and omeprazole — do I take any medications that could interact with inavolisib in a way that might affect my safety or the drug's effectiveness?
5Because this trial is no longer enrolling, are there any published or preliminary results from it that you've seen, and how should those findings — or the absence of them — factor into the treatment choices we're considering right now?
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.
What they're measuring
1
Blinded Independent Central Review (BICR)-Assessed Progression Free Survival (PFS)
Timeframe: From randomization until disease progression or death due to any cause (up to approximately 64 months)
2
Sub-study: Maximum observed Drug Concentration (Cmax) for Midazolam
Timeframe: Day -4 and -3 of Cycle (C) 1, Day (D) 11 and C1D12. A cycle is 28 days.
3
Sub-study: Cmax for Bupropion
Timeframe: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.
4
Sub-study: Cmax for Omeprazole
Timeframe: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
5
Sub-study: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC [0-last]) for Midazolam
Timeframe: Day -4 and -3 of C1D11 and C1D12. A cycle is 28 days.
6
Sub-study: AUC (0-last) for Bupropion
Timeframe: Day -3, -2, -1 of C1D1, C1D12, C1D13, C1D14 and C1D15. A cycle is 28 days.