Trials / Recruiting
RecruitingNCT06304857
CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
A Multicentre, Randomised, Double-blind, Placebo-controlled Phase III Study, Evaluating the Effect of Dapagliflozin on Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Anthracycline-based Chemotherapy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- Sponsor
- 4th Military Clinical Hospital with Polyclinic, Poland · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is a multicentre, randomised, double-blind, placebo-controlled phase III study, evaluating the effect of dapagliflozin versus placebo on prevention of cardiotoxicity in breast cancer patients undergoing anthracycline-based chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin | 10 mg tablet q.d |
| DRUG | Placebo | tablet matching dapagliflozin 10 mg q.d |
Timeline
- Start date
- 2024-04-15
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2024-03-12
- Last updated
- 2024-12-04
Locations
3 sites across 1 country: Poland
Source: ClinicalTrials.gov record NCT06304857. Inclusion in this directory is not an endorsement.