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

RecruitingObservational study

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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

What is being tested

Sponsor: UNC Lineberger Comprehensive Cancer Center · Participants: 10,000 · Started: Dec 1, 1998

Contact the study team

Official record on ClinicalTrials.gov — NCT01000883

Locations in the U.S.

North CarolinaLineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

Conditions

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.