Phase 2
N=11
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
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02177175 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Jul 2022
Primary outcome: Primary: Maximum Change in LVEF at 3 Months — 1; -5 change in percent ejection fraction
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carvedilol (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Change in LVEF at 3 Months |
1; -5 | — |
| PRIMARY Maximum Change in LVEF at 6 Months |
-2; -5 | — |
| PRIMARY Maximum Change in LVEF at 9 Months |
-3.5; -5.5 | — |
| PRIMARY Maximum Change in LVEF at 12 Months |
-2.5; -2 | — |
| SECONDARY Incidence of Abnormal LVEF at 12 Months |
2; 1; 3; 5 | — |
Summary
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).
Eligibility Criteria
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 ( 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
Data sourced from ClinicalTrials.gov (NCT02177175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.