Could a diabetes pill boost chemo response in breast cancer? new study investigates.
NCT ID NCT05989347
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study looks at whether adding dapagliflozin, a diabetes drug, to standard chemotherapy changes insulin-related markers in the blood. It involves 20 women with early-stage HER2-negative breast cancer who also have high insulin levels. The goal is to gather safety data and understand how the drug affects insulin resistance, not to treat the cancer directly.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 chemotherapy regimens are acceptable: 1. Weekly or dose dense paclitaxel, followed by dose dense doxorubicin plus cyclophosphamide 2. Docetaxel plus cyclophosphamide 3. Docetaxel plus carboplatin plus or minus pembrolizumab 4. Paclitaxel plus carboplatin concurrent with every 3 week pembrolizumab followed by dose dense doxorubicin plus cyclophosphamide concurrent with every 3 week pembrolizumab (KEYNOTE-522 regimen; only for participants with triple negative breast cancer) * 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: 1. peripheral granulocyte count of \> 1,500/mm3 2. platelet count \> 100,000/mm3 3. hemoglobin \>9 g/dL 4. total bilirubin \< 1.5 x upper limit of normal (ULN) 5. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each \< 1.5 x ULN 6. serum creatinine \< 1.5 x ULN 7. INR/PT/PTT each \< 1.5 x ULN * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale Cancer Center Smilow Cancer Hospital
RECRUITINGNew Haven, Connecticut, 06520, United States
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Other studies related to the condition(s) this trial covers.
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