Clinical trial · Interventional
Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification
NCT02177175CI-TRIAL-00059623completedPhase 2Results postedClinicalTrials.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 purpose of this study is to find out the effects, good and/or bad, of a beta blocker (carvedilol) on heart function during treatment with anti-HER2 medication(s) including trastuzumab (Herceptin).
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carvedilol | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carvedilol
- description
- Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
- interventionNames
- Drug: Carvedilol
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Treatment in both carvedilol and placebo groups will be systematically up-titrated at weeks 3, 6, and 9 (+/- 1 week) after randomization to a goal dose of 25mg twice daily.
- interventionNames
- Other: placebo
Primary outcomes (4)
- measure
- Maximum Change in LVEF at 3 Months
- timeFrame
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 carcinoma * Pathologically confirmed HER2-positive breast cancer * Scheduled to receive anthracycline chemotherapy followed by anti-HER2 therapy at MSKCC * Able and willing to provide informed consent * Willing and able to comply with the requirements of the protocol * Able to swallow capsules For Aim 2, all patients must meet the following criteria: * Meet all inclusion criteria above * LVEF \> 50% * Abnormal global longitudinal strain (\<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-HER2 therapy * Heart rate ≥ 50 beats per minute * Sitting systolic blood pressure \> 90 mmHg Exclusion Criteria: * Patients are to be excluded from randomization for Aim 2 of this study if they meet any of the following criteria: * Current treatment with ACE-inhibitors or beta blockers * Allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or AV block. * Known history of NCI CTCAE (Version 4.0) Grade ≥ 2 symptomatic CHF, myocardial infarction within 12 months prior to randomization, significant symptoms (Grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (Grade ≥ 3) * Pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment * Enrollment in a therapeutic intervention trial in the Breast Medicine service
References
Publications (1)
- DERIVEDYu AF, Moore ZR, Moskowitz CS, Liu JE, Dang CT, Ramanathan L, Oeffinger KC, Steingart RM, Schmitt AM. Association of Circulating Cardiomyocyte Cell-Free DNA With Cancer Therapy-Related Cardiac Dysfunction in Patients Undergoing Treatment for ERBB2-Positive Breast Cancer. JAMA Cardiol. 2023 Jul 1;8(7):697-702. doi: 10.1001/jamacardio.2023.1229. PMID 37256614