RecruitingPhase 1

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

A Pilot Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy for Patient With HER2-negative Early-stage Breast Cancer and Hyperinsulinemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests dapagliflozin given with chemotherapy before breast cancer surgery. It looks at safety and blood markers that show how well the body responds to insulin, a hormone that controls blood sugar. It is for women over 18 with newly diagnosed, early-stage HER2-negative breast cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women over 18 with stage I–III invasive breast cancer confirmed by a tissue sample. The cancer must be HER2-negative and either estrogen receptor-positive or triple-negative.
  • Need chemotherapy before surgery and plan to receive one of the study’s allowed treatment plans.
  • Have a body mass index (BMI) of at least 25 and an insulin resistance test score (HOMA-IR) of at least 2.5.
  • Willing and able to sign a consent form and swallow the study medicine.
  • Have at least one stained tissue slide from the biopsy that diagnosed the cancer.
  • Have been past menopause for at least 1 year or had surgery to prevent pregnancy. Otherwise, pregnancy testing must be negative, and birth control rules apply if sexually active with a male partner who is not sterile.
  • Have blood counts, liver and kidney function, and blood clotting test results that meet the study’s limits for chemotherapy.
  • Do not donate blood during the study or for at least 90 days after the last chemotherapy dose.

Who can't join

  • Have had breast or lymph node surgery that prevents an accurate check of how the cancer responds to treatment.
  • Are pregnant or breastfeeding, or cannot safely receive any planned chemotherapy.
  • Have type 1 or type 2 diabetes, or took diabetes medicines that affect insulin levels or insulin resistance in the past month.
  • Have had an allergic reaction to dapagliflozin, or have a kidney filtering test result (eGFR) below 25.
  • Have had 3 or more urinary tract infections in 12 months, or 2 or more in 6 months.
  • Are in a weight loss program, had a weight change greater than 5% of current body weight in the past 3 months, or have had surgery on the digestive system.
  • Received a live vaccine within 30 days before the first study treatment, or receive one during the study.
  • The study doctor believes you are unlikely to follow the study’s steps, limits, or requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

CT