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Dapagliflozin with Neoadjuvant Therapy for HER2-negative Breast Cancer

This study is looking at how a drug called dapagliflozin (10mg daily) affects women with newly diagnosed HER2-negative breast cancer who are receiving chemotherapy before surgery (neoadjuvant therapy). Researchers want to see if dapagliflozin can help lower insulin resistance, which is when your body doesn't respond well to insulin. They will measure changes in insulin resistance using a test called HOMA-IR at different times during your treatment. The study also wants to make sure dapagliflozin is safe to take with your chemotherapy. You may be able to join if you are a woman over 18 with this type of breast cancer and are scheduled for neoadjuvant chemotherapy. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is a single-arm, open-label study, meaning all participants will receive dapagliflozin, and both you and the study team will know you are receiving it. It plans to enroll 20 women.
What's involved
You would take dapagliflozin 10mg daily throughout your chemotherapy treatment. Blood tests for insulin resistance (HOMA-IR) will be done at the start, after paclitaxel treatment (week 12), and two weeks after all neoadjuvant therapy.
Compensation
Not stated in the trial record.
Follow-up
Your insulin resistance will be measured up to two weeks after your neoadjuvant therapy is completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05989347

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

Recruiting
PHASE1Ages 18+InterventionalBasic science
Yale University
~20 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Dapagliflozin 10mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Measured over baseline, post paclitaxel treatment at week 12, and 2 weeks post neoadjuvant therapy

Conditions

Breast Cancer
Hyperinsulinism
HER2-negative Breast Cancer

Explore related trials

Breast CarcinomaHOMA-IR

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Maryam Lustberg, MD, MPH · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Carl Brown
[email protected]
475-241-1065
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 chemotherapy regimens are acceptable:
BMI ≥ 25 kg/m2
Hyperinsulinemia defined as HOMA-IR ≥ 2.5.
Willing and able to provide written informed consent for the trial.
Has at least one (1) physical 4-5-micron single H\&E slide from diagnostic biopsy available
Female participants of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female participants must be 1 year post-menopausal orsurgically sterile, Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to follow their chemotherapy provider's instructions for birth control.
Participants should have adequate organ function to tolerate chemotherapy, as defined by:
Able to swallow oral formulation of the study agent
Subjects should not donate blood while participating in this study, or for at least 90 days following the last dose of chemotherapy

Exclusion

Participants who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node biopsy and therefore cannot be assessed accurately for pathologic response, are not eligible.
Participants currently pregnant or breastfeeding.
Participants for whom any of the planned chemotherapies are contraindicated.
Participants with currently diagnosed type I or II diabetes mellitus.
Participants taking any antidiabetic medication that would affect insulin resistance or hyperinsulinemia (i.e. TZD, GLP-1RA, DPP-4i, SGLT2i, metformin) in the past one month.
Participants with history of hypersensitivity reaction to dapagliflozin.
Participants with eGFR \< 25.
History of recurrent (three or more occurrences within 12 months, or two or more occurrences within 6 months) urinary tract infections.
Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) or have a history of gastrointestinal surgery.
Live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, intranasal influenza, rabies, BCG, and typhoid vaccine.
Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.

What this trial measures

  • Change in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)baseline, post paclitaxel treatment at week 12, and 2 weeks post neoadjuvant therapy

    Change in HOMA-IR (calculated as fasting insulin (μU/ml) x fasting glucose (mmol/l) divided by 22.5.