Clinical Trials Directory

Trials / Completed

CompletedNCT04023110

Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab

A Pilot Study of Risk-Guided Cardioprotection With Carvedilol in Breast Cancer Patients Treated With Doxorubicin and/or Trastuzumab

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
68 (actual)
Sponsor
Abramson Cancer Center at Penn Medicine · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

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 trastuzumab is safe, tolerable, and feasible. Subjects who are identified as having elevated CTX Risk by an internally validated clinical risk score (exceeding a pre-specified risk threshold) will be randomized to individually-dosed, open-label carvedilol or usual care. Investigators will use a stratified randomization according to trastuzumab therapy (yes/no) to ensure balance across treatment regimen. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and standardized time intervals during and after therapy at approximately 3, 6, 9, 12, and 24 months.

Conditions

Interventions

TypeNameDescription
DRUGCarvedilolIndividually dosed carvedilol

Timeline

Start date
2019-08-09
Primary completion
2024-08-31
Completion
2025-01-14
First posted
2019-07-17
Last updated
2025-10-09
Results posted
2025-10-09

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04023110. Inclusion in this directory is not an endorsement.