Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy

Sponsor
University of Campinas, Brazil
Study ID
NCT06711185
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin 10 mg — DRUG
    Patients in this group will receive 1 tablet of 10mg dapagliflozin daily for 9 months, starting 7-10 days before chemotherapy treatment.
  • Placebo — OTHER
    Patients in this group will receive 1 placebo tablet per day, with identical characteristics to the group receiving dapagliflozin, for 9 months, starting 7-10 days before the start of chemotherapy treatment

Study Details

Prospective, randomized, double-blind, controlled clinical trial to compare the effect of 9 months of treatment with dapagliflozin vs. placebo on anthracycline-induced cardiotoxicity in patients with breast cancer.

Key Dates

Start date
Jan 30, 2024
Status verified
Nov 2024
Primary completion
Jan 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Standard chemotherapy treatment + Dapagliflozin 10mg/day.
  • Placebo Comparator: Placebo Group
    Standard chemotherapy treatment + Placebo.

Primary Outcome Measure

Change in left ventricle ejection fraction [ Time Frame: 36 weeks ]

Central Contacts

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