Evaluating the protective effects of dapagliflozin against heart damage from chemotherapy in breast cancer patients
Study Phase II "Proof of Concept", National Multi-centered. Randomised 1:1, Evaluate Whether Dapagliflozin Reduces Chemotherapy Induced Cardiotoxicity in Participants With Breast Cancer Treated With (Neo-) Adjuvant Anthracycline-based Chemotherapy +/- Trastuzumab
This study is testing if dapagliflozin can help protect the hearts of women with early-stage breast cancer from damage caused by chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 316 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Drugs / interventions | trastuzumab, Chemotherapy, Pertuzumab, doxorubicin |
| Locations | 1 site (Pavia) |
| Trial ID | NCT06341842 on ClinicalTrials.gov |
What this trial studies
This study investigates whether dapagliflozin can mitigate cardiotoxicity caused by anthracycline-based chemotherapy in women with stage I-III breast cancer. Participants who are chemotherapy-naive and scheduled to receive treatment will be enrolled and randomly assigned to receive either dapagliflozin or standard care. The study aims to assess the efficacy of dapagliflozin in preserving heart function during chemotherapy. By focusing on patients receiving targeted therapies like trastuzumab, the study seeks to address a significant complication associated with effective cancer treatments.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18 to 70 who are chemotherapy-naive and scheduled for anthracycline-based treatment for stage I-III breast cancer.
Not a fit: Patients with a left ventricular ejection fraction below 53% or those with significant valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart health and better treatment outcomes for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have shown some success with SGLT-2 inhibitors in reducing heart failure risks, but this specific application in chemotherapy-induced cardiotoxicity is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 . Exclusion Criteria: * Left ventricular ejection fraction (LVEF) \<53%\* * 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
Where this trial is running
Pavia
- Fondazione IRCCS Policlinico San Matteo — Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Laura Scelsi, Cardiologist
- Email: l.scelsi@smatteo.pv.it
- Phone: +390382501326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.