Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT06341842
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab. The study aims to describe the efficacy for dapagliflozin as compared to standard of care. Participants will be recruited in participating centers, where they are planning on starting (neo-) adjuvant ACT-based chemotherapy and/or trastuzumab for stage I-III breast cancer.

Key Dates

Start date
Oct 19, 2023
Status verified
Mar 2024
Primary completion
Apr 19, 2025
Completion
Apr 19, 2025

Study Design

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

Arms

  • Experimental: Active group - Dapagliflozin 10 mg
  • No Intervention: Control group - Standard of care

Primary Outcome Measure

Assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up. [ Time Frame: baseline, 3 months, 6 months, 12 months and 18 months. ]

Central Contacts

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