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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
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

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
  • 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

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,911 Previous Clinical Trials
4,250,652 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 Nov 2025
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