CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL

Sponsor
4th Military Clinical Hospital with Polyclinic, Poland
Study ID
NCT06304857
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    10 mg tablet q.d
  • Placebo — DRUG
    tablet matching dapagliflozin 10 mg q.d

Study Details

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.

Key Dates

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

Study Design

Enrollment
188 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg tablet orally once daily for 12 months
  • Placebo Comparator: Placebo
    Placebo tablet matching dapagliflozin orally once daily for 12 months

Primary Outcome Measure

Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. [ Time Frame: 12 months ]

Central Contacts

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