Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin a… (NCT04023110) | Clinical Trial Compass
CompletedPhase 1
Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab
United States68 participantsStarted 2019-08-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 \< 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 bradycard…