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New treatment option for Breast Cancer
Official title CardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL
ClinicalTrials.gov ID: NCT06304857
What this study is testing
What is Dapagliflozin?
Dapagliflozin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as Farxiga, Forxiga.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wroclaw, Lower Silesian Voivodeship, Poland
- Warsaw, Masovian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wroclaw, Lower Silesian Voivodeship, Poland; Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.