Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

Breast Cancer Clinical Trial

Official title: Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study

Status Recruiting

Clinical Trial Summary

The majority of patients (pts) with breast cancer have hormone receptor positive (HR+) disease, and this holds true for pts with advanced breast cancer (ABC). Currently frontline therapy for pts with HR+ ABC is antihormonal therapy with an aromatase inhibitor or selective estrogen receptor degrader plus a CDK4/6i. The proposed trial is a randomized study to further evaluate the potential benefit of switching a frontline regimen at the time that a molecular signal, ctDNA, suggests progression prior to detection of clinical progression using standard methods. The purpose of this study is to determine whether switching treatment earlier in the disease process, based on molecular progression, will increase the amount of time that a patient's metastatic breast cancer is controlled compared to patients with metastatic breast cancer who receive treatment later based on diagnostic imaging results or other methods currently used in medical practice.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• ER-positive Breast Cancer
• HER2-negative Breast Cancer
• Metastatic Breast Cancer

• NCT number: NCT05826964
• Study type: Interventional
• Source: University of Miami
• Contact: Frances Valdes-Albini, MD
• Phone: 305-243-5302
• Email: fvalbini@med.miami.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: June 12, 2023
• Completion date: July 31, 2029