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

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ClinicalTrials.gov Identifier: NCT01000883
Recruitment Status : Recruiting
First Posted : October 23, 2009
Last Update Posted : June 9, 2022
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief 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

Condition or disease Intervention/treatment
Breast Cancer Other: biologic sample preservation procedure Other: laboratory biomarker analysis Procedure: biopsy

Detailed Description:


  • 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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
Actual Study Start Date : December 1, 1998
Estimated Primary Completion Date : November 2030
Estimated Study Completion Date : November 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Other: biologic sample preservation procedure
    approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.
  • Other: laboratory biomarker analysis
    Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.
  • Procedure: biopsy
    cancer tissue will be taken from the primary breast cancer site as well as the metastatic tumor sites. Two tubes of whole blood will also be collected.

Primary Outcome Measures :
  1. Generation of a biorepository for current and future correlative research studies [ Time Frame: Diagnosis, between treatments,7-14 days after start of treatment and at time of definitive therapy ]

Biospecimen Retention:   Samples With DNA
Primary tumor and metastatic site tumor tissue; whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be selected from those individuals receiving diagnostic and treatment related biopsies at the University of North Carolina at Chapel Hill.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000883

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Contact: Adrianna Warner (919) 966-7847 adrianna_warner@med.unc.edu
Contact: Erin Kelly (919) 966-0040 erin_kelly@med.unc.edu

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United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Lisa A. Carey, MD UNC Lineberger Comprehensive Cancer Center
Additional Information:
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01000883    
Other Study ID Numbers: LCCC 9819
P50CA058223 ( U.S. NIH Grant/Contract )
P30CA016086 ( U.S. NIH Grant/Contract )
05-2015 Also (05-MED-521-ORC) ( Other Identifier: IRB assigned number )
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases