OncoMatch/Clinical Trials/NCT05989347
Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant with Neoadjuvant Therapy
Is NCT05989347 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies Dapagliflozin 10mg for breast cancer.
Treatment: Dapagliflozin 10mg — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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
Demographics
Prior therapy
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 →Frequently asked questions
Is NCT05989347 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages