To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (NCT07368998) | Clinical Trial Compass
RecruitingPhase 2
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
United States, Argentina, Australia80 participantsStarted 2026-02-18
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
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:
* Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting
* 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
* Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation
* Life expectancy of \> 6 months
* Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes
Exclusion Criteria:
* Metaplastic breast cancer
* Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting
* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
* Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting
* Requirement for daily supplemental oxygen
* Symptomatic active lung disease, including pneumonitis
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.
What they're measuring
1
Percentage of Participants With Objective Response Rate (ORR)
Timeframe: Up to approximately 2 years
2
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 2 years
Trial details
NCT IDNCT07368998
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-10-31
Contact for this trial
Reference Study ID Number: WO46063 https://forpatients.roche.com/ No attachments to email below.