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Potential protective role of SGLT-2 inhibitors for chemotherapy-induced cardiotoxicity (PROTECT trial)
EU CTIS ID: 2024-518611-18-00
What this study is testing
The study seeks primarily to assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Chemotherapy-naive patients, scheduled for antracycline +/- trastuzumab treatment in the (neo-)adjuvant setting for stage I-III breast cancer
- Adult women between 18 and 70 years of age
- eGFR>25 ml/min/1.7 mq
- ECOG score 0-2Consent form signed.
- Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a negative result from a serum pregnancy test performed within 7 days of randomization and on the day of first study treatment prior to the initiation of study treatment. Women of childbearing potential must agree to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug. Women of childbearing potential willing to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug
You likely can't join if
- Left ventricular ejection fraction (LVEF) <53% (Current echocardiography recommendations set low normal value of 2D LVEF as 54% for women and 52% for men and hence in the 2016 EACVI position statement a reduction of LVEF below 53% was classified as abnormal)
- Valvular heart disease
- Previous malignancy requiring treatment with anthracyclines or chest radiotherapy
- A life expectancy of ≤12 weeks
- Currently pregnant (confirmed with positive pregnancy test performed from -7 to -1 days prior to start study drug) or unwilling to adopt highly effective contraceptive method
- Currently breast-feeding women
See the full eligibility criteria
- Chemotherapy-naive patients, scheduled for antracycline +/- trastuzumab treatment in the (neo-)adjuvant setting for stage I-III breast cancer
- Adult women between 18 and 70 years of age
- eGFR>25 ml/min/1.7 mq
- ECOG score 0-2Consent form signed.
- Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a negative result from a serum pregnancy test performed within 7 days of randomization and on the day of first study treatment prior to the initiation of study treatment. Women of childbearing potential must agree to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug. Women of childbearing potential willing to use highly effective contraceptive measures from the time of informed consent through 7 months after last dose of study drug
- Left ventricular ejection fraction (LVEF) <53% (Current echocardiography recommendations set low normal value of 2D LVEF as 54% for women and 52% for men and hence in the 2016 EACVI position statement a reduction of LVEF below 53% was classified as abnormal)
- Valvular heart disease
- Previous malignancy requiring treatment with anthracyclines or chest radiotherapy
- A life expectancy of ≤12 weeks
- Currently pregnant (confirmed with positive pregnancy test performed from -7 to -1 days prior to start study drug) or unwilling to adopt highly effective contraceptive method
- Currently breast-feeding women
- History of hypersensitivity to dapagliflozin or any of the excipients of the product
- History of Diabetic Ketoacidosis (DKA) requiring medical intervention (e.g. emergency room visit and/or hospitalization) within 1 month prior to enrolment visit
- Type 1 diabetes mellitus
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.