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Biguanide

Dapagliflozin for Breast Cancer (EPIK-B4 Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
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 7.4 months
Awards & highlights

EPIK-B4 Trial 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

EPIK-B4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7.4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7.4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Hyperglycemia Grade ≥ 3 Over the First Eight Weeks of Alpelisib Plus Fulvestrant Treatment
Secondary outcome measures
Clinical Benefit Rate (CBR) With Confirmed Response Based on Local Investigator Assessment as Per RECIST 1.1
Number of Participants With Dose Modifications
Overall Response Rate (ORR) With Confirmed Response Based on Local Investigator Assessment as Per RECIST 1.1.
+1 more

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

EPIK-B4 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Alpelisib + Fulvestrant + Dapagliflozin + Metformin XRExperimental Treatment5 Interventions
Alpelisib 300mg administered orally once daily starting at Cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received a combination treatment of dapagliflozin+metformin XR (as a single tablet or as two separate tablets, at the discretion of the investigator) at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily which could be titrated to a maximum dose of 10 mg dapagliflozin + 2000 mg metformin XR once daily.
Group II: Alpelisib + Fulvestrant + Metformin XRActive Control3 Interventions
Alpelisib 300mg administered orally once daily starting at cycle 1 Day 8 in combination with fulvestrant 500mg intramuscular at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle. Participants also received metformin XR 500mg orally once daily which could be titrated to a maximum dose of 2000 mg once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64880
Alpelisib
2018
Completed Phase 3
~900
Fulvestrant
2011
Completed Phase 3
~3690
Metformin XR
2013
Completed Phase 4
~9220

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,351 Total Patients Enrolled
87 Trials studying Breast Cancer
37,810 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Dapagliflozin obtained regulatory affirmation from the FDA?

"Taking into consideration that Dapagliflozin is in Phase 2 of clinical trials, meaning it has some evidence for safety but none for efficacy, our team at Power assigned a rating score of 2."

Answered by AI

Is Dapagliflozin being studied in any other medical investigations?

"The original studies of dapagliflozin were conducted at George Washington University in 2002. Now, there are 1344 completed investigations and 375 ongoing experiments with numerous trials based out of Jacksonville, Florida."

Answered by AI

Is there an ongoing recruitment process for this experiment?

"Per the information from clinicaltrials.gov, this medical experiment is actively recruiting individuals. The study was initially posted on April 6th 2022 and its most recent update came in November 10th of that same year."

Answered by AI

How many participants are invited to join this experiment?

"132 eligible participants are sought for this research. Potential candidates may be found at Mayo Clinic Jacksonville in Florida or the Rochester Oncology Department of Mayo Clinic in Minnesota."

Answered by AI

What ailments has Dapagliflozin been found to effectively ameliorate?

"Dapagliflozin is generally used for exercise therapy and can be beneficial in managing type 1 diabetes mellitus, diabetic ketoacidosis, as well as specific dietary regimens."

Answered by AI

How many healthcare establishments have been commissioned to administer this trial?

"At this time, 20 different clinical sites are recruiting patients for the trial. These include Jacksonville, Rochester and Durham amongst other locations. To reduce travel strain, it is important to find a medical centre close by when considering enrollment in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
2022. "Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04899349.
~1 spots leftby Apr 2025
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