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OncoMatch/Clinical Trials/NCT06304857

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

Is NCT06304857 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Dapagliflozin for breast cancer.

Phase 3Recruiting4th Military Clinical Hospital with Polyclinic, PolandNCT06304857Data as of May 2026

Treatment: DapagliflozinThe 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Disease stage

Required: Stage I, II, III

Excluded: Stage IV

Lab requirements

Blood counts

Anemia with Hemoglobin < 9 g/dl excluded

Kidney function

eGFR < 25 ml/min/1.73m2 according to CKD EPI excluded; Kidney failure > G2 (according to KDIGO classification) excluded

Liver function

Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm excluded; Liver disorders, Child-Pugh score > 4 excluded

Cardiac function

Left ventricular ejection fraction < 50% at screening excluded; severe valvular heart disease, history of clinically significant arrhythmia, history of stroke, cardiomyopathy, pulmonary hypertension, uncontrolled arterial pressure or systolic pressure < 80 mmHg at screening excluded

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). Alanine transaminase or aspartate transaminase levels above 2.5 times the local norm. Anemia with Hemoglobin < 9 g/dl. Kidney failure > G2 (according to KDIGO classification). Liver disorders, Child-Pugh score > 4.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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