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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05989347
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg — DRUG
    10 mg tablets for oral administration daily throughout chemotherapy treatment

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dapagliflozin
    All participants (with insulin resistance and Estrogen Receptor (ER)+HER2-negative or ER/Progesterone receptor (PR)/HER2-negative breast cancer) will receive current standard of care neoadjuvant chemotherapy as determined by the treating physician, plus dapagliflozin 10 mg orally taken daily throughout chemotherapy treatment.

Primary Outcome Measure

Change in Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) [ Time Frame: baseline, post paclitaxel treatment at week 12, and 2 weeks post neoadjuvant therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale Cancer Center Smilow Cancer HospitalNew HavenConnecticut06520-

Find similar trials in New Haven, CT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Yale Cancer Center Smilow Cancer Hospital· New Haven, CT

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