Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT05989347

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

Led by Yale University · Updated on 2025-03-19

20

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women over 18 years old with newly diagnosed clinical stage I-III HER2-negative invasive breast cancer eligible for neoadjuvant chemotherapy
  • Acceptable chemotherapy regimens include weekly paclitaxel followed by doxorubicin and cyclophosphamide, docetaxel plus cyclophosphamide, docetaxel plus carboplatin with or without pembrolizumab, or paclitaxel plus carboplatin with pembrolizumab (KEYNOTE-522 regimen)
  • Body mass index of 25 kg/m2 or higher
  • Hyperinsulinemia defined by HOMA-IR score of 2.5 or greater
  • Able and willing to provide written informed consent
  • Availability of at least one physical biopsy slide from diagnostic tissue
  • Female participants of childbearing potential must have a negative pregnancy test and agree to birth control if sexually active with a non-sterilized male partner
  • Female participants must be at least one year post-menopausal or surgically sterile
  • Adequate organ function as defined by specified blood counts and liver, kidney, and coagulation parameters
  • Ability to swallow oral medication
  • Agreement not to donate blood during the study and for 90 days after last chemotherapy dose
Not Eligible

You will not qualify if you...

  • Previous partial breast surgery or biopsy that prevents accurate assessment of pathologic response
  • Currently pregnant or breastfeeding
  • Contraindications to planned chemotherapy regimens
  • Diagnosis of type 1 or 2 diabetes mellitus
  • Use of antidiabetic medications affecting insulin resistance within the past month
  • History of allergic reaction to dapagliflozin
  • Estimated glomerular filtration rate (eGFR) less than 25
  • History of recurrent urinary tract infections
  • Participation in weight loss programs, significant recent weight change, or history of gastrointestinal surgery
  • Receipt of live vaccines within 30 days before starting treatment or during the trial
  • Investigator judgment that participant may not comply with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yale Cancer Center Smilow Cancer Hospital

New Haven, Connecticut, United States, 06520

Actively Recruiting

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Research Team

C

Carl Brown

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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