OncoMatch/Clinical Trials/NCT05753657
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.
Is NCT05753657 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies Pioglitazone for metastatic breast cancer.
Treatment: Pioglitazone — The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: PIK3CA activating mutation
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05753657 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require PIK3CA?
Yes, PIK3CA activating mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages