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.

Phase 1

Recruiting

• Conditions: Patients with invasive breast cancer, on stage I-III, and planned anthracycline treatment within 60 days.; MedDRA version: 20.0Level: LLTClassification code: 10061033Term: Cardiomyopathy secondary Class: 10007541; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-506631-15-00
• Lead Sponsor: 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-05
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

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.

Exclusion Criteria

Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment., BMI > 40 kg/m2., Diagnosed type 1 or type 2 diabetes or fasting glucose = 126 mg/dl or HbA1C = 6,5% (48 mmol/mol) including newly diagnosed at screening., Pregnancy or breastfeeding., Lack of compliance to use highly effective method of birth control., Expected or possible treatment with epirubicin or liposomal doxorubicin within 12 months., Taking another study drug or drugs from the group of SGLT2 inhibitors up to 6 months before the screening visit., Taking semaglutide, liraglutide and metformin during the 30 days preceding the screening visit., eGFR < 25 ml/min/1.73m2 according to CKD EPI., Life expectancy < 12 months or cancer disease stage IV according to the TNM classification., ALAT/ ASPAT above 2.5 times the local norm., Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure., Anemia with Hgb < 9 g/dl., Kidney failure > G2 (KDIGO)., Liver disorders, Child-Pugh classification > 4pkt., Known, active infections with HIV, HBV, HCV, tuberculosis., Any other condition which, in the opinion of the investigator, makes it impossible to fulfil the requirements for participation in this study., Left ventricular ejection fraction < 50% at the time of the screening., Severe valvular heart disease., A history of clinically significant arrhythmia, including atrial fibrillation regardless of type (at discretion of the investigator)., A history of stroke., Cardiomyopathy: congenital, post-inflammatory, toxic, infiltrative (e.g. amyloidosis, sarcoidosis, haemochromatosis), postnatal or hypertrophic., Pulmonary hypertension., Uncontrolled arterial pressure or systolic pressure < 80 mmHg at screening at the discretion of the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified