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S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity

NCT03418961 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 491

Last updated 2025-10-08

No results posted yet for this study

Summary

This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.

Conditions

  • Cardiotoxicity
  • HER2/Neu Positive
  • Metastatic Malignant Neoplasm in the Brain
  • Recurrent Breast Carcinoma
  • Stage IV Breast Cancer AJCC v6 and v7

Interventions

DRUG

Carvedilol

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Patient Observation

Undergo observation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Justin Floyd · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2027-09-15
Completion
2027-09-15
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico
  • Saudi Arabia
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03418961 on ClinicalTrials.gov