A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Partic… (NCT07748208) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
40 participantsStarted 2026-09-01
Plain-language summary
This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.
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:
* Type 2 diabetes with laboratory fasting blood glucose \< 185 milligrams per deciliter (mg/dL) and HbA1c \<= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing
* Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease
* Confirmed diagnosis of HR+/HER2- breast cancer
* Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Adequate hematologic and organ function within 14 days prior to initiation of study treatment
Exclusion Criteria:
* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Metaplastic breast cancer
* Any history of Type 1 diabetes
* Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment
* Any history of leptomeningeal disease or carcinomatous meningitis
* Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible
* Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
* Symptomatic active lung disease
* History of active bowel inflammation o…
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 specifically designed for people with both advanced breast cancer and Type 2 diabetes — given that I have both conditions, does my doctor think my current blood sugar control is stable enough to safely participate, and how closely would my glucose levels be monitored during treatment?
2The primary thing this Phase 2 trial is measuring is serious hyperglycemia — including Grade 4 high blood sugar events and hospitalizations — so does my doctor think the added blood sugar risk from combining inavolisib with these other drugs is something my current diabetes management could handle?
3Since this trial isn't recruiting yet, how long might it be before it opens, and is waiting for it a reasonable option compared to starting a standard treatment like fulvestrant or palbociclib now?
4Inavolisib targets the PI3K pathway, which is known to affect blood sugar regulation — can my doctor explain how that interacts with my diabetes medications, and whether any adjustments to my diabetes treatment would likely be needed?
5If I were to discuss this trial with my care team, would I need to involve both my oncologist and my endocrinologist or diabetes doctor to manage both conditions safely throughout the study?
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 Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1
Timeframe: Up to approximately 21 months
2
Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1
Timeframe: Up to approximately 21 months
3
Percentage of Participants with AEs After Cycle 1
Timeframe: Up to approximately 21 months
Trial details
NCT IDNCT07748208
SponsorHoffmann-La Roche
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-06-15
Contact for this trial
Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.