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

  • STATUS
    Recruiting
  • End date
    Nov 19, 2032
  • participants needed
    10000
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
Updated on 19 June 2022
stage iv breast cancer

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

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.

Details
Condition Breast Cancer
Treatment laboratory biomarker analysis, biopsy, biologic sample preservation procedure
Clinical Study IdentifierNCT01000883
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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