Status:
COMPLETED
Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
American Heart Association
Conditions:
Cardiotoxicity
Risk Factor, Cardiovascular
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 undergo...
Detailed Description
This is a single-center, randomized clinical trial that seeks to determine if a risk guided treatment strategy that initiates carvedilol in high risk breast cancer patients prior to doxorubicin and/or...
Eligibility Criteria
Inclusion
- 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
- 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 \< 90mmHg (if multiple blood pressures are available in the medical record within 1 month prior to screening, the average SBP will be considered)
- Baseline heart rate \< 55 bpm consistent with severe bradycardia (if multiple resting heart rates are available in the medical record within 1 month prior to screening, the average heart rate will be considered)
- Allergy to carvedilol
- History of bronchial asthma or related bronchospastic conditions
- Known history of sick sinus syndrome
- Severe hepatic impairment, defined as serum bilirubin \> 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
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04023110
Start Date
August 9 2019
End Date
January 14 2025
Last Update
October 9 2025
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104