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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort — INSIGHT  

Metastatic Breast Cancer Clinical Trial

Official title:
Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

Clinical Trial Summary

This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)

Clinical Trial Description

Primary Objective: - Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Secondary Objectives: - Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer - Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Correlatives: - Determine if the tumor mutations detected in cfDNA are early surrogates of response - Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05693766
Study type Interventional
Source Vanderbilt-Ingram Cancer Center
Contact Vanderbilt-Ingram Services for Timely Access
Phone 800-811-8480
Email cip@vumc.org
Status Recruiting
Phase Phase 2
Start date September 11, 2023
Completion date August 31, 2037
View Details
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