Plasma Circulating Tumor DNA Analyses in ER+ Metastatic Breast Cancer

NCT03161834 | Withdrawn

• 2 other identifiers: LCCC 164216-2952
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Breast Cancer

Keywords

DNA; Circulating tumor cells

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Prediction

  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.

  Through study completion, an average of 3-6 weeks

Secondary Outcomes (2)

• DNA Analysis of Hotspot Mutation Prevalence

  Through study completion, an average of 3-6 weeks

• DNA Analysis of Mutation and Radiographic Response Correlation

  Through study completion, an average of 3-6 weeks

Interventions

Observational OTHER

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Females with metastatic breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Females with ER+ metastatic breast cancer receiving 2nd, 3rd, or 4th line systemic endocrine therapy

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill Cancer Hospital

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

10 mL blood samples

MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Gaorav P Gupta, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 22, 2017
• Study Start: January 13, 2017
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)