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NCT01000883Recruiting

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

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
10000 (estimated)
First submitted
22 Oct 2009
Start date
1 Dec 1998
Primary completion date
30 Nov 2030
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
NCT number
NCT01000883

What you commit to

  • Study type: Observational
  • Planned participants: 10000
  • From 1 Dec 1998 to the primary completion date, 30 Nov 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.
  • 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.

Other illness

  • 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)
  • Cardiac disease making it unsafe to biopsy in the opinion of the treating physician.

Who the study is looking for

  • 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.)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.