Safety of inavolisib and fulvestrant in advanced breast cancer with diabetes
Tests the safety of inavolisib plus fulvestrant in adults with breast cancer and diabetes.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Key facts
- Where
- Dorado, Puerto RicoSee the site
- Phase
- Phase 2
Where in Puerto Rico
- Pan American Center for Oncology Trials, LLCDorado, Puerto RicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hoffmann-La Roche
- Trial code
- NCT07748208
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes
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.
Inclusion: 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: Metaplastic breast cancer; Any history of Type 1 diabetes; 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 or active inflammatory bowel disease; Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required; Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment.