No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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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 outType 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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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