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.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Breast Cancer Trials on Trialify →