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

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

FACILITYZIPCITYSTATE
MedStar Washington Hosp Center20010Washington D.C.District of Columbia
Grady Memorial Hospital30303-3031AtlantaGeorgia
Emory University Hospital Midtown30308-2212AtlantaGeorgia
Emory University Hospital30322AtlantaGeorgia
Nebraska Cancer Specialists St Francis - Grand Island68803Grand IslandNebraska
Nebraska Cancer Specialists68114OmahaNebraska
NYU Langone Hospital Long Island Clinical Research11501-4089MineolaNew York
NYU Langone?s Perlmutter Cancer Center - 160 E 34th St10016-4744New YorkNew York
West Virginia University26506-1200MorgantownWest Virginia

Get This Program In Your Inbox

You can sign up and apply your patients for this program.