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OncoMatch/Clinical Trials/NCT05989347

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

Is NCT05989347 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Dapagliflozin 10mg for breast cancer.

Phase 1RecruitingYale UniversityNCT05989347Data as of May 2026

Treatment: Dapagliflozin 10mgThe 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) negative

HER2-negative - either ER+ or triple negative - invasive breast cancer as defined by ASCO CAP guidelines

Allowed: ESR1 positive

either ER+ or triple negative

Disease stage

Required: Stage I, II, III

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

peripheral granulocyte count of > 1,500/mm3; platelet count > 100,000/mm3; hemoglobin >9 g/dL

Kidney function

serum creatinine < 1.5 x ULN; eGFR < 25 excluded

Liver function

total bilirubin < 1.5 x ULN; AST and ALT each < 1.5 x ULN

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 ULN; AST and ALT each < 1.5 x ULN; serum creatinine < 1.5 x ULN; INR/PT/PTT each < 1.5 x ULN

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Yale Cancer Center Smilow Cancer Hospital · New Haven, Connecticut

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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