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Trial Title:
CardioPROTECTion With Dapagliflozin in Breast Cancer Patients Treated With AnthrAcycline - PROTECTAA TRIAL
NCT ID:
NCT06304857
Condition:
Breast Cancer
Heart Failure
Conditions: Official terms:
Breast Neoplasms
Heart Failure
Dapagliflozin
Conditions: Keywords:
breast cancer
heart failure
ejection fraction
anthracyclines
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Dapagliflozin
Description:
10 mg tablet q.d
Arm group label:
Dapagliflozin
Other name:
Farxiga
Other name:
Forxiga
Intervention type:
Drug
Intervention name:
Placebo
Description:
tablet matching dapagliflozin 10 mg q.d
Arm group label:
Placebo
Summary:
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
4th Military Clinical Hospital with Polyclinic
Address:
City:
Wrocław
Zip:
50-981
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Bartosz Krakowiak, PhD, MD
Phone:
+48 261 660 234
Email:
bkrakowiak@4wsk.pl
Facility:
Name:
Lower Silesian Centre for Oncology, Lung Diseases and Hematology
Address:
City:
Wrocław
Zip:
53-413
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Rafał Matkowski, PhD, MD
Facility:
Name:
Military Medical Institute
Address:
City:
Warsaw
Zip:
04-141
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Paweł Krzesiński, PhD, MD
Start date:
April 15, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
4th Military Clinical Hospital with Polyclinic, Poland
Agency class:
Other
Source:
4th Military Clinical Hospital with Polyclinic, Poland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304857
