Recruiting NCT06304857
CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin, Placebo.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Heart Failure. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
This is a multicentre, randomised, double-blind, placebo-controlled phase III study, evaluating the effect of dapagliflozin versus placebo on prevention of cardiotoxicity in breast cancer patients undergoing anthracycline-based chemotherapy.
Interventions
- Drug Dapagliflozin
10 mg tablet q.d - Drug Placebo
tablet matching dapagliflozin 10 mg q.d
Primary outcome measures
- Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months. [Time frame: 12 months]
Secondary outcome measures (12)
- Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months. [Time frame: 6 months]
- Change in left ventricular ejection fraction at 6 and 12 months. [Time frame: 6 and 12 months]
- Change in left ventricular diastolic function at 6 and 12 months. [Time frame: 6 and 12 months]
- Change in Troponin I after 6 and 12 months. [Time frame: 6 and 12 months]
- Change in NTproBNP levels at 6 and 12 months. [Time frame: 6 and 12 months]
- Quality of life at 6 and 12 months assessed using the five-dimensional EQ-5D questionnaire. [Time frame: 6 and 12 months]
- Occurrence of death from any cause. [Time frame: 13 months (additional 1 month of safety follow-up after end of treatment).]
- Composite endpoint of cardiovascular events. [Time frame: 13 months (additional 1 month of safety follow-up after end of treatment).]
- Occurrence of death from any cardiovascular reasons. [Time frame: 13 months (additional 1 month of safety follow-up after end of treatment).]
- Occurrence of non-fatal myocardial infarction. [Time frame: 13 months (additional 1 month of safety follow-up after end of treatment).]
- Occurrence of non-fatal stroke. [Time frame: 13 months (additional 1 month of safety follow-up after end of treatment).]
- Occurrence of hypoglycaemia. [Time frame: 13 months (additional 1 month of safety follow-up after end of treatment).]
Eligibility criteria
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Poland · 3 centers
- 4th Military Clinical Hospital with Polyclinic — Wroclaw
- Lower Silesian Centre for Oncology, Lung Diseases and Hematology — Wroclaw
- Military Medical Institute — Warsaw
Identifiers
NCT: NCT06304857 · 2022/ABM/01/00039 · 2023-506631-15-00