CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
NCT ID: NCT06304857
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
188 participants
INTERVENTIONAL
2024-04-15
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Dapagliflozin
Dapagliflozin 10 mg tablet orally once daily for 12 months
Dapagliflozin
10 mg tablet q.d
Placebo
Placebo tablet matching dapagliflozin orally once daily for 12 months
Placebo
tablet matching dapagliflozin 10 mg q.d
Interventions
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Dapagliflozin
10 mg tablet q.d
Placebo
tablet matching dapagliflozin 10 mg q.d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.
* 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).
* BMI \> 40 kg/m2.
* Diagnosed type 1 or type 2 diabetes or fasting glucose ≥ 126 mg/dl or HbA1C ≥ 6,5% (48 mmol/mol).
* 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.
* 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.
* Known, active infections with HIV, HBV, HCV, tuberculosis.
* Any other condition which, in the opinion of the investigator, makes it impossible to fulfill the requirements for participation in this study.
18 Years
80 Years
ALL
No
Sponsors
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4th Military Clinical Hospital with Polyclinic, Poland
OTHER
Responsible Party
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Principal Investigators
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Waldemar Banasiak, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
4th Military Clinical Hospital with Polyclinic
Locations
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4th Military Clinical Hospital with Polyclinic
Wroclaw, Lower Silesian Voivodeship, Poland
Lower Silesian Centre for Oncology, Lung Diseases and Hematology
Wroclaw, Lower Silesian Voivodeship, Poland
Military Medical Institute
Warsaw, Masovian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Rafał Matkowski, PhD, MD
Role: primary
Paweł Krzesiński, PhD, MD
Role: primary
Other Identifiers
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2023-506631-15-00
Identifier Type: OTHER
Identifier Source: secondary_id
2022/ABM/01/00039
Identifier Type: -
Identifier Source: org_study_id