Phase 1
N=68
Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
Cardiotoxicity · Risk Factor, Cardiovascular · Toxicity Due to Chemotherapy · Breast Cancer · Cardiomyopathies
Bottom Line
View on ClinicalTrials.gov: NCT04023110 ↗Enrolled (actual)
68
Serious AEs
2.9%
Results posted
Oct 2025
Primary outcome: Primary: Left Ventricular Ejection Fraction (LVEF) — 61.1; 59.0; 61.9; 58.4 percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Carvedilol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Ejection Fraction (LVEF) |
61.1; 59.0; 61.9; 58.4; 60.4; 59.7 | — |
| PRIMARY Treatment Adherence as Measured by Pill Count |
93 | — |
| PRIMARY Adverse Events |
11; 8; 47; 6; 2; 15 | — |
| SECONDARY Diastolic Function (E/e') by Echocardiogram |
7.86; 6.85; 7.64; 8.22; 8.24; 7.06 | — |
| SECONDARY Ventricular-arterial Coupling Measured by Echocardiogram |
0.76; 0.84; 0.71; 0.83; 0.88; 0.82 | — |
| SECONDARY Cardiac Strain Measurements by Echocardiogram |
-20.7; -20.5; -21.8; -21.1; -20.0; -21.3 | — |
| SECONDARY Frequency of Individuals With Cardiac Dysfunction |
0; 0; 1 | — |
| SECONDARY High-sensitivity Troponin (hsTnT) Level |
6.1; 8.0; 5.7; 7.4; 6.2; 7.2 | — |
| SECONDARY N-terminal Pro B-type Natriuetic Peptide (NTproBNP) Level |
88.4; 54.8; 98.4; 126.8; 32.6; 52.0 | — |
| SECONDARY Left Ventricular Mass |
110.6; 95.3; 98; 92.2; 98.4; 94.5 | — |
Summary
Investigators will evaluate the safety, tolerability, and feasibility of a risk-guided cardioprotective treatment strategy with carvedilol, as compared to usual care, in breast cancer patients undergoing treatment with doxorubicin, trastuzumab, or the combination.
Eligibility Criteria
Inclusion Criteria
- Females
- At least 18 years old
- Diagnosed with Stage I-III breast cancer with treatment plan to include therapy with anthracyclines and/or trastuzumab in the adjuvant or neo-adjuvant setting
- Study team is able to obtain all necessary information for calculating Cardiotoxicity Risk Score (including echocardiographic measurement of left ventricular ejection fraction)
Exclusion Criteria
- Pregnant or breast feeding. Due to unknown risks and potential harm to the unborn fetus a negative pregnancy test within 10 days prior to enrollment is required in women with child-bearing potential. Due to the potential nursing infant harm, women who are currently breast feeding are not eligible for this study.
- Contraindication to carvedilol
- Baseline systolic blood pressure 3.0x ULN, AST or ALT > 5.0 ULN within 28 days of enrollment
- Second- or third-degree AV block, as determined by electrocardiogram
- Severe bradycardia (unless permanent pacemaker is in place)
- Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy
- Current use of: Bupropion (Wellbutrin), Fluoxetine (Prozac), Paroxetine (Paxil), Quinidine (Quinidex), Duloxetine (Cymbalta), Digoxin
- Current treatment with beta blocker
- Unable to provide consent
Data sourced from ClinicalTrials.gov (NCT04023110). 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.