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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 (Jun 2026). This Phase 3 trial studies Dapagliflozin for breast cancer.

Phase 3Recruiting4th Military Clinical Hospital with Polyclinic, PolandNCT06304857Data as of Jun 2026Location: Poland

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

Treatments studied

Other

Dapagliflozin

Cancer type

Breast Carcinoma

Disease stage

Required: Stage I, II, III

Excluded: Stage IV

Demographics

Ages ≤ 80

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.

Frequently asked questions

Is NCT06304857 currently recruiting?

Yes, this trial is currently recruiting patients.

What disease stage is eligible?

Stage I or II or III is required.

Is there an age limit?

Yes. Patients must be 80 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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