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NCT07748208
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
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.
Trial Details
NCT ID NCT07748208
Phase PHASE2
Sponsor Hoffmann-La Roche
Status RECRUITING
Cancer Type Breast Cancer
Interventions Inavolisib Fulvestrant Palbociclib
Locations (sample) Washington D.C., District of Columbia, United States|38.89511,-77.03637 Atlanta, Georgia, United States|33.749,-84.38798 Atlanta, Georgia, United States|33.749,-84.38798 Atlanta, Georgia, United States|33.749,-84.38798 Grand Island, Nebraska, United States|40.92501,-98.34201
Key Eligibility Criteria
Type 2 diabetes with laboratory fasting blood glucose \< 185 milligrams per deciliter (mg/dL) and HbA1c \<= 8% on any stable anti-hyperglycemic reg… 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)
For full eligibility, visit ClinicalTrials.gov .
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