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Dapagliflozin 10Mg Tab for Breast Cancer

Phase 2
Waitlist Available
Led By Timothy J Pluard, MD
Research Sponsored by Saint Luke's Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial tests if adding dapagliflozin to alpelisib and fulvestrant can better manage high blood sugar and improve treatment for patients with a specific type of breast cancer. Dapagliflozin is used to treat type 2 diabetes.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 2 study of Fulvestrant, alpelisib and dapagliflozinExperimental Treatment1 Intervention
A cycle length is defined as 28 days. Fulvestrant 500 mg intramuscular, Cycle 1, Day 1 and Day 15; Cycle 2 and beyond 500 mg Intramuscular Day 1. Alpelisib 300 mg by mouth, daily, continuously beginning on Cycle 1, Day 1. Dapagliflozin 10 mg by mouth, daily, continuously beginning Cycle 1, Day 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
FDA approved

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor
2,889 Previous Clinical Trials
4,201,979 Total Patients Enrolled
88 Trials studying Breast Cancer
37,756 Patients Enrolled for Breast Cancer
Saint Luke's Health SystemLead Sponsor
41 Previous Clinical Trials
12,921 Total Patients Enrolled
Timothy J Pluard, MDPrincipal InvestigatorSaint Luke's Cancer Institute
~6 spots leftby Sep 2025
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