Dapagliflozin for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerDapagliflozin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new combination of drugs for people with breast cancer that has progressed after other treatments. The new combination is dapagliflozin plus metformin extended release, and it will be compared to metformin extended release to see if it is more effective and safe.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: From the date of randomization up to a maximum duration of 12 cycles.(1 cycle = 28 days)

Day 8
Number of Participants With Hyperglycemia Grade ≥ 3 over the first eight weeks of alpelisib treatment
Day 56
Number of Participants With Hyperglycemia Grade ≥ 3 over the first two cycles of treatment
Day 28
Progression-free Survival (PFS) Per Investigator Assessment
Day 28
Clinical Benefit Rate (CBR) with confirmed response
Overall Response Rate (ORR) with confirmed response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Dapagliflozin
20%Cervicovaginal infection
13%Urinary tract infections
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT03006471) in the Dapagliflozin ARM group. Side effects include: Cervicovaginal infection with 20%, Urinary tract infections with 13%.

Trial Design

3 Treatment Groups

Alpelisib + Fulvestrant + Metformin
1 of 3
Alpelisib + Fulvestrant + Metformin XR
1 of 3
Alpelisib + Fulvestrant + Dapagliflozin + Metformin XR
1 of 3

Active Control

Experimental Treatment

2 Total Participants · 3 Treatment Groups

Primary Treatment: Dapagliflozin · No Placebo Group · Phase 2

Alpelisib + Fulvestrant + Dapagliflozin + Metformin XRExperimental Group · 5 Interventions: Dapagliflozin, Fulvestrant, Alpelisib, Dapagliflozin + metformin XR, Metformin XR · Intervention Types: Drug, Drug, Drug, Drug, Drug
Alpelisib + Fulvestrant + MetforminActiveComparator Group · 1 Intervention: Alpelisib + Fulvestrant + Metformin · Intervention Types:
Alpelisib + Fulvestrant + Metformin XRActiveComparator Group · 3 Interventions: Fulvestrant, Alpelisib, Metformin XR · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved
Fulvestrant
FDA approved
Alpelisib
FDA approved
Metformin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of randomization up to a maximum duration of 12 cycles.(1 cycle = 28 days)

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,719 Previous Clinical Trials
3,525,267 Total Patients Enrolled
80 Trials studying Breast Cancer
30,397 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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