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Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior | Clinical Trials | Clareo Health

RECRUITING

Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior

NCT01000883•UNC Lineberger Comprehensive Cancer Center

Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at tissue and blood samples from women with locally advanced or metastatic breast cancer

Detailed Description

OBJECTIVES: * Collect , catalogue, and store biological specimens from patients with locally advanced or metastatic breast cancer * To collect clinical data from these patients containing identifiers, demographics, epidemiologic review, clinical evaluation, treatment, and long-term follow-up. * To provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research. OUTLINE: This is a multicenter study. Patients undergo core biopsy and blood sampling at diagnosis, between chemotherapy regimens, and prior to definitive surgery. Tumor markers are assessed using immunohistochemistry and flow cytometry. PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•High suspicion of or known breast cancer (early or metastatic)
•Lesion accessible for safe biopsy (as deemed by the treating physician).
•Age ≥ 18 years.
•ECOG performance status 0 - 2.
•Ability to understand and willingness to sign an informed consent document.
•If receiving therapeutic anticoagulation; it should be discontinued temporarily prior to biopsy for a length of time to be determined by the study doctor.
•Adequate marrow function, defined as absolute neutrophil count ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L required only for biopsies of vital organs (lung, liver, etc.)

Exclusion Criteria

•Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.
•Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
•History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)
•Pregnant women are excluded because there may be an increased risk to both mother and fetus in the setting of conscious sedation, which is required for biopsies of certain anatomic sites (e.g. liver, lung). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus.
•Cardiac disease making it unsafe to biopsy in the opinion of the treating physician.
•If patients receiving bevacizumab or other angiogenesis inhibitors are less than 6 weeks from last dose of the angiogenesis inhibitor, they should not undergo research core biopsies of vital organs (lung, liver, etc.) on this protocol because of the concern for the possibility of increased bleeding risk and delayed healing. Patients receiving bevacizumab or other angiogenesis inhibitors who are undergoing a research biopsy of the breast, peripheral lymph node or a skin punch biopsy must be two weeks from the last dose of the angiogenesis inhibitor.

Locations (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Key Dates

Start Date

December 1, 1998

Primary Completion Date

November 1, 2030

Completion Date

November 1, 2032

Last Updated

June 18, 2025

Enrollment

10,000

ESTIMATED participants

Conditions

Breast Cancer

Interventions

biologic sample preservation procedure

OTHER

laboratory biomarker analysis

OTHER

biopsy

PROCEDURE

Contacts

Adrianna Warner

CONTACT

(919) 966-7847 adrianna_warner@med.unc.edu

Erin Kelly

CONTACT

(919) 966-0040 erin_kelly@med.unc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior

Inclusion Criteria

Exclusion Criteria

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