A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Sponsor: Hoffmann-La Roche
Sponsor score: 40
ClinicalTrials ID:NCT07748208
This study assesses the safety of inavolisib with fulvestrant, with or without palbociclib, in patients with PIK3CA-mutated, HR+/HER2- advanced breast cancer and type 2 diabetes. Eligible participants must have controlled diabetes, no prior systemic therapy for advanced disease, and meet specific health criteria. Interventions include oral inavolisib, IM fulvestrant, and optional oral palbociclib.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Eligibility Criteria
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 or active inflammatory bowel disease
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MedStar Washington Hosp Center | 20010 | Washington D.C. | District of Columbia |
| Grady Memorial Hospital | 30303-3031 | Atlanta | Georgia |
| Emory University Hospital Midtown | 30308-2212 | Atlanta | Georgia |
| Emory University Hospital | 30322 | Atlanta | Georgia |
| Nebraska Cancer Specialists St Francis - Grand Island | 68803 | Grand Island | Nebraska |
| Nebraska Cancer Specialists | 68114 | Omaha | Nebraska |
| NYU Langone Hospital Long Island Clinical Research | 11501-4089 | Mineola | New York |
| NYU Langone?s Perlmutter Cancer Center - 160 E 34th St | 10016-4744 | New York | New York |
| West Virginia University | 26506-1200 | Morgantown | West Virginia |
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