Dapagliflozin 10Mg Tab for Breast Cancer

Saint Luke's Cancer Institute, Kansas City, MO

Targeting 2 different conditionsDapagliflozin 10Mg TabPhase 2RecruitingLed by Timothy J Pluard, MDResearch 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

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upthrough study completion, an average of 1 year.

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Study Summary

This trial will test if adding dapagliflozin to alpelisib + fulvestrant reduces hyperglycemia in patients with HR+/HER2- mBC.

Eligible Conditions

Metastatic Breast Cancer
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of all grade hyperglycemia as assessed by CTCAE v5.0

Secondary outcome measures

Incidence of Grade 3/4 hyperglycemia as assessed by CTCAE v5.0

Overall response rate (ORR) as assed by RECIST 1.1 in patients with measurable disease

Progression free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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

Fulvestrant

FDA approved

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor

2,799 Previous Clinical Trials

4,024,251 Total Patients Enrolled

85 Trials studying Breast Cancer

34,601 Patients Enrolled for Breast Cancer

Saint Luke's Health SystemLead Sponsor

41 Previous Clinical Trials

12,921 Total Patients Enrolled

Timothy J Pluard, MDPrincipal Investigator

Saint Luke's Cancer Institute

Frequently Asked Questions

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

Are there vacancies for participants in this clinical investigation?

"Clinicaltrials.gov states that recruitment for this trial is ongoing, and the listing was first posted on August 25th 2021 before being updated lastly on October 14th 2021."

Answered by AI

In what clinical scenarios is Dapagliflozin 10Mg Tab typically recommended?

"Dapagliflozin 10Mg Tab is a viable therapeutic option for the management of dietary changes, pi3k gene mutation, an unresponsiveness to single drug intervention, and breast cancer."

Answered by AI

Does this medical trial have an age threshold for participants?

"Patients of legal age (over 18) and below 65 are eligible for this clinical trial."

Answered by AI

How does the risk-benefit profile of Dapagliflozin 10Mg Tab compare to other treatments?

"As this is a Phase 2 trial, indicating that there are some safety data but no efficacy data available yet, Dapagliflozin 10Mg Tab was given a score of two."

Answered by AI

Are there any prior experiments concerning the effectiveness of Dapagliflozin 10Mg Tab?

"At present, there are 213 clinical studies probing the effects of Dapagliflozin 10Mg Tab with 45 trials in Phase 3. The bulk of these investigations are taking place in Shanghai, although altogether 7531 sites across the globe are participating."

Answered by AI

Am I eligible to become a participant in this trial?

"To be eligible, participants must have a diagnosis of breast cancer and lie within the 18-65 age range. This trial seeks to enrol 25 volunteers in total."

Answered by AI

What is the capacity for participation in this medical research project?

"Absolutely. Clinicaltrials.gov's records show that this medical trial is actively searching for participants, with the original post having been uploaded on August 25th 2021 and updated most recently on October 14th 2021. The aim of the study is to recruit a total of 25 patients from 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alpelisib, Fulvestrant and Dapagliflozin for the Treatment of HR+, HER2 -, PIK3CA Mutant Metastatic Breast Cancer

Timothy Pluard, MD 2021. "Alpelisib, Fulvestrant and Dapagliflozin for the Treatment of HR+, HER2 -, PIK3CA Mutant Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05025735.