A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1 — Up to approximately 21 months
- Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1 — Up to approximately 21 months
- Percentage of Participants with AEs After Cycle 1 — Up to approximately 21 months
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| MedStar Washington Hosp Center | Washington D.C. | District of Columbia | Recruiting |
| Grady Memorial Hospital | Atlanta | Georgia | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | Recruiting |
| Emory University Hospital | Atlanta | Georgia | Recruiting |
| Nebraska Cancer Specialists St Francis - Grand Island | Grand Island | Nebraska | Recruiting |
| Nebraska Cancer Specialists | Omaha | Nebraska | Recruiting |
| NYU Langone Hospital Long Island Clinical Research | Mineola | New York | Recruiting |
| NYU Langone?s Perlmutter Cancer Center - 160 E 34th St | New York | New York | Recruiting |
| West Virginia University | Morgantown | West Virginia | Recruiting |
| Pan American Center for Oncology Trials, LLC | Dorado | Puerto Rico | Recruiting |
On this site
📄 Ibrance (palbociclib) drug profile →More Hoffmann-La Roche trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07748208 on ClinicalTrials.gov ↗ ← All trials in the USA