NCT03161834

Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer

LCCC 1642: Plasma Circulating Tumor DNA (ctDNA) Analyses in ER+ Metastatic Breast Cancer

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether increased mutant ESR1 allele fraction in plasma ctDNA 3-6 weeks after initiating salvage endocrine therapy is predictive of progression free survival in patients with ER+ metastatic breast cancer.

Detailed description

The primary objective of this 110 patient correlative biomarker study is to evaluate whether changes in mutant ESR1 allele fraction in plasma circulating tumor DNA (ctDNA) are predictive of progression-free survival in metastatic ER+ breast cancer patients who are receiving 2nd, 3rd, or 4th line systemic endocrine therapy. A secondary goal of this study is to explore the prevalence and kinetics of hotspot and non-hotspot ctDNA ESR1 mutations in this patient population, prior to initiating a new line of endocrine therapy as well as upon clinical progression, to identify potential mechanisms of resistance. Although initially to be opened at UNC Chapel Hill, our goal is to expand enrollment to include Rex Cancer Center in Raleigh, North Carolina, and collaborating institutions through the Translational Breast Cancer Research Consortium.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
OTHER	Observational

Timeline

• Start date: 2017-01-13
• Primary completion: 2020-07-09
• Completion: 2020-07-09
• First posted: 2017-05-22
• Last updated: 2021-05-21

Locations

1 site across 1 country: United States