Breast Cancer Clinical Trial

Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years of age
Female gender
Biopsy proven diagnosis of breast cancer
Stage IV disease diagnosed either by radiographic studies or biopsy
ER+ by immunohistochemistry on primary and/or metastatic tissue biopsy (>10%)
HER2 non-amplified (1+ or below by immunohistochemistry, and/or Her2 FISH <2 HER2-to-CEP17 ratio)
Progressed on at least one prior line of endocrine therapy for metastatic disease
Three or fewer prior endocrine-containing therapies for recurrent/metastatic disease
Two or fewer prior lines of cytotoxic chemotherapy for recurrent/metastatic disease
Plans to initiate 2nd, 3rd, or 4th line endocrine therapy for metastatic disease
Recent re-staging scans within 4 weeks of study enrollment, with radiographically identifiable disease
No concurrent or prior diagnosis of malignancy other than breast cancer for the past 5 years. Patients with a history of in situ cancer or basal or localized squamous cell skin cancer remain eligible
Intends to pursue treatment as well as clinical and radiographic follow-up at UNC Health Care
Signed an institutional review board (IRB)-approved informed consent document for this protocol and HIPAA consent form

Exclusion Criteria:

< 18 years of age
Tissue biopsies that support the presence of both ER+ and ER- metastatic breast cancer in the same patient
Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Pregnant or lactating women

Study is for people with:

Breast Cancer

Study ID:

NCT03161834

Recruitment Status:

Withdrawn

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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University of North Carolina at Chapel Hill Cancer Hospital
Chapel Hill North Carolina, 27599, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Study ID:

NCT03161834

Recruitment Status:

Withdrawn

Sponsor:


UNC Lineberger Comprehensive Cancer Center

How clear is this clinincal trial information?

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