RecruitingPhase 1NCT05989347

Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant with Neoadjuvant Therapy

A Pilot Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant with Neoadjuvant Therapy for Patient with HER2-negative Early-stage Breast Cancer and Hyperinsulinemia


Sponsor

Yale University

Enrollment

20 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of the study is to assess metabolic plasma markers of insulin resistance in patients with early-stage HER2-negative breast cancers receiving dapagliflozin concomitant with neoadjuvant therapy.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding dapagliflozin — a diabetes drug that also has heart and kidney benefits — to standard pre-surgery chemotherapy (neoadjuvant therapy) for certain breast cancers is safe and changes helpful biological markers. **You may be eligible if...** - You are a woman over 18 with newly diagnosed invasive breast cancer (clinical stage I-III) - Your breast cancer is HER2-negative (either hormone receptor-positive or triple-negative) - Your treatment plan includes pre-surgery chemotherapy **You may NOT be eligible if...** - Your breast cancer is HER2-positive - You are not scheduled for pre-surgery chemotherapy - You have certain health conditions that make it unsafe to take dapagliflozin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDapagliflozin 10mg

10 mg tablets for oral administration daily throughout chemotherapy treatment


Locations(1)

Yale Cancer Center Smilow Cancer Hospital

New Haven, Connecticut, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05989347


Related Trials