Recruiting
Phase 2

Inavolisib & Fulvestrant, Palbociclib

Sponsor:

Hoffmann-La Roche

Code:

NCT07748208

Conditions

Breast Cancer

Diabetes Type II

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inavolisib

Fulvestrant

Palbociclib

Study Details

Brief 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.

Conditions

Breast Cancer

Diabetes Type II

Study ID

NCT07748208

Start date

Oct 30, 2026

Status verified date

Oct, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Jun 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inavolisib + Fulvestrant + Palbociclib

Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.

Interventions

Inavolisib

Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.

Fulvestrant

Participants will receive intramuscular (IM) fulvestrant on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.

Palbociclib

Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Primary outcome measure

  • Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1 [ Time Frame: Up to approximately 21 months ]
  • Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1 [ Time Frame: Up to approximately 21 months ]
  • Percentage of Participants with AEs After Cycle 1 [ Time Frame: Up to approximately 21 months ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

Locations

MedStar Washington Hosp Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303-3031

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308-2212

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Nebraska Cancer Specialists St Francis - Grand Island

Recruiting

Grand Island, Nebraska, United States, 68803

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68114

NYU Langone Hospital Long Island Clinical Research

Recruiting

Mineola, New York, United States, 11501-4089

NYU Langone?s Perlmutter Cancer Center - 160 E 34th St

Recruiting

New York, New York, United States, 10016-4744

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506-1200

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.