Clinical trial · Interventional
Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab
Role of ACE Inhibitors and Beta Blockers as Cardiotoxicity Prevention in Breast Cancer Patients Treated With (Neo)Adjuvant Anthracyclines and/or Trastuzumab: a Four Arm, Placebo Control, Randomized Trial
NCT02236806CI-TRIAL-00056263SAFEunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bisoprolol | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| Ramipril | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- bisoprolol plus ramipril
- interventionNames
- Drug: Bisoprolol
- Drug: Ramipril
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Bisoprolol plus placebo
- interventionNames
- Drug: Bisoprolol
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Arm 3
- description
- Ramipril plus placebo
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age \>18 years * Non-metastatic histologically confirmed primary invasive breast cancer * Scheduled to receive neoadjuvant and/or adjuvant anthracyclines with or without anti-HER2 therapy * Provided informed consent * Able to swallow capsules * LVEF \> 50% Exclusion Criteria: * Pregnant or lactating women * Treatment with ACE-inhibitors or beta blockers at diagnosis * History of NCI Common Toxicity Criteria for Adverse Effects (CTCAE) (version 4.0) Grade \>2 symptomatic congestive heart failure (CHF), previous myocardial infarction, significant symptoms (Grade\>2) relating to LVEF dysfunction, valvular disease, cardiac arrhythmia (Grade\>3)
References
Publications (4)
- BACKGROUNDFrancolini G, Desideri I, Meattini I, Becherini C, Terziani F, Olmetto E, Delli Paoli C, Pezzulla D, Loi M, Bonomo P, Greto D, Calusi S, Casati M, Pallotta S, Livi L. Assessment of a guideline-based heart substructures delineation in left-sided breast cancer patients undergoing adjuvant radiotherapy : Quality assessment within a randomized phase III trial testing a cardioprotective treatment strategy (SAFE-2014). Strahlenther Onkol. 2019 Jan;195(1):43-51. doi: 10.1007/s00066-018-1388-x. Epub 2018 Nov 7. PMID 30406290
- BACKGROUNDMeattini I, Curigliano G, Terziani F, Becherini C, Airoldi M, Allegrini G, Amoroso D, Barni S, Bengala C, Guarneri V, Marchetti P, Martella F, Piovano P, Vannini A, Desideri I, Tarquini R, Galanti G, Barletta G, Livi L. SAFE trial: an ongoing randomized clinical study to assess the role of cardiotoxicity prevention in breast cancer patients treated with anthracyclines with or without trastuzumab. Med Oncol. 2017 May;34(5):75. doi: 10.1007/s12032-017-0938-x. Epub 2017 Mar 31. PMID 28364270
- RESULTLivi L, Barletta G, Martella F, Saieva C, Desideri I, Bacci C, Del Bene MR, Airoldi M, Amoroso D, Coltelli L, Scotti V, Becherini C, Visani L, Salvestrini V, Mariotti M, Pedani F, Bernini M, Sanchez L, Orzalesi L, Nori J, Bianchi S, Olivotto I, Meattini I. Cardioprotective Strategy for Patients With Nonmetastatic Breast Cancer Who Are Receiving an Anthracycline-Based Chemotherapy: A Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1544-1549. doi: 10.1001/jamaoncol.2021.3395. PMID 34436523
- DERIVEDMarrazzo L, Meattini I, Becherini C, Salvestrini V, Visani L, Barletta G, Saieva C, Del Bene MR, Pilato G, Desideri I, Arilli C, Paoletti L, Russo S, Scoccianti S, Martella F, Francolini G, Simontacchi G, Nori Cucchiari J, Pellegrini R, Livi L, Pallotta S. Subclinical cardiac damage monitoring in breast cancer patients treated with an anthracycline-based chemotherapy receiving left-sided breast radiation therapy: subgroup analysis from a phase 3 trial. Radiol Med. 2024 Dec;129(12):1926-1935. doi: 10.1007/s11547-024-01897-6. Epub 2024 Oct 22. PMID 39436588