Dapagliflozin with Neoadjuvant Therapy for Breast Cancer

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

Recruiting Phase 1 Interventional Study
Breast Cancer Hyperinsulinism HER2-negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
20 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for

This trial is looking for women with early-stage HER2-negative breast cancer who are planning to receive chemotherapy. Participants will take a medication called dapagliflozin while undergoing treatment to help assess certain health markers.

Are You a Good Fit for This Trial?
Rules you out Type 1 diabetesType 2 diabetes

You may be able to join if

  • I am a woman over 18 years old.
  • I have been diagnosed with HER2-negative breast cancer.
  • I have a body mass index (BMI) of 25 or higher.
  • I have high insulin levels.
  • I can provide informed consent for the trial.
  • I have a physical slide from a biopsy available.
  • I am not pregnant or breastfeeding.
  • I have enough organ function to tolerate chemotherapy.

You may not be able to join if

  • I have had certain types of breast surgery that affect treatment assessment.
  • I am currently pregnant or breastfeeding.
  • I have diabetes.
  • I have taken specific diabetes medications in the past month.
  • I have an allergy to dapagliflozin.
  • I have a low kidney function.
  • I have had multiple urinary tract infections recently.
  • I am currently part of a weight loss program.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Women \> 18 years of age with newly diagnosed, histologically confirmed, clinical stage I-III, HER2-negative - either ER+ or triple negative - invasive breast cancer as defined by ASCO CAP guidelines for whom neoadjuvant chemotherapy would be indicated. The following chemother…
Contacts

Carl Brown

475-241-1065

carl.brown@yale.edu

CONTACT