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
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Age \> 18 years and \< 80 years.
• Diagnosis of invasive breast cancer \[stage I-III\] and planned anthracycline treatment within 60 days.
• Signed Informed Consent to participate in the study.
Locations
Other Locations
Poland
Military Medical Institute
RECRUITING
Warsaw
4th Military Clinical Hospital with Polyclinic
RECRUITING
Wroclaw
Lower Silesian Centre for Oncology, Lung Diseases and Hematology
RECRUITING
Wroclaw
Contact Information
Primary
Bartosz Krakowiak, PhD, MD
bkrakowiak@4wsk.pl
+48 261 660 234
Time Frame
Start Date: 2024-04-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 188
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: 4th Military Clinical Hospital with Polyclinic, Poland