NCT07748208RecruitingPhase 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
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 15 Jun 2029
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Metastatic breast cancer, Type 2 diabetes
- NCT number
- NCT07748208
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 30 Oct 2026 to the primary completion date, 15 Jun 2029
- 10 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pan American Center for Oncology Trials, LLC Coordinator of this site? Confirm its status | Dorado | Puerto Rico | Recruiting |
| Emory University Hospital Midtown Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Emory University Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Grady Memorial Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Nebraska Cancer Specialists St Francis - Grand Island Coordinator of this site? Confirm its status | Grand Island | United States | Recruiting |
| NYU Langone Hospital Long Island Clinical Research Coordinator of this site? Confirm its status | Mineola | United States | Recruiting |
| West Virginia University Coordinator of this site? Confirm its status | Morgantown | United States | Recruiting |
| NYU Langone?s Perlmutter Cancer Center - 160 E 34th St Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Nebraska Cancer Specialists Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| MedStar Washington Hosp Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.