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Tests treatment safety and results for Breast Cancer
Official title Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
ClinicalTrials.gov ID: NCT05989347
What this study is testing
What is Dapagliflozin 10mg?
Dapagliflozin 10mg is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women \> 18 years of age with newly diagnosed, histologically confirmed, clinical stage I-III, HER2-negative - either ER+ or triple negative -...
- Weekly or dose dense paclitaxel, followed by dose dense doxorubicin plus cyclophosphamide
- Docetaxel plus cyclophosphamide
- Docetaxel plus carboplatin plus or minus pembrolizumab
- Paclitaxel plus carboplatin concurrent with every 3 week pembrolizumab followed by dose dense doxorubicin plus cyclophosphamide concurrent with every...
You likely can't join if
- Participants who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node biopsy and...
- 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...
- Participants with history of hypersensitivity reaction to dapagliflozin.
See the full eligibility 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...
- Weekly or dose dense paclitaxel, followed by dose dense doxorubicin plus cyclophosphamide
- Docetaxel plus cyclophosphamide
- Docetaxel plus carboplatin plus or minus pembrolizumab
- 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...
- 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...
- Participants should have adequate organ function to tolerate chemotherapy, as defined by:
- peripheral granulocyte count of \> 1,500/mm3
- platelet count \> 100,000/mm3
- hemoglobin \>9 g/dL
- total bilirubin \< 1.5 x upper limit of normal (ULN)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each \< 1.5 x ULN
- serum creatinine \< 1.5 x ULN
- INR/PT/PTT each \< 1.5 x ULN
- Able to swallow oral formulation of the study agent
- people should not donate blood while participating in this study, or for at least 90 days following the last dose of chemotherapy
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.