NCT05989347 Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
| NCT ID | NCT05989347 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Yale University |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-10-15 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Maryam Lustberg, MD, MPH
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05989347 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05989347 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05989347 currently recruiting?
Yes, NCT05989347 is actively recruiting participants. Contact the research team at carl.brown@yale.edu for enrollment information.
Where is the NCT05989347 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05989347 clinical trial?
NCT05989347 is sponsored by Yale University. The principal investigator is Maryam Lustberg, MD, MPH at Yale University. The trial plans to enroll 20 participants.
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