Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy
NCT05989347 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-22
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.
Conditions
- Breast Cancer
- Hyperinsulinism
- HER2-negative Breast Cancer
Interventions
- DRUG
-
Dapagliflozin 10mg
10 mg tablets for oral administration daily throughout chemotherapy treatment
Sponsors & Collaborators
-
Yale University
lead OTHER
Principal Investigators
-
Maryam Lustberg, MD, MPH · Yale University
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-15
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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