Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer

Withdrawn before enrolling

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID

NCT03161834

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

0

Starts

2017-01-13

Expected to finish

2020-07-09

Last updated by the study team

2021-05-21

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• < 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

Where it is running

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

Full record on ClinicalTrials.gov

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