Breast Cancer
Conditions
Keywords
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
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
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.
Interventions
OTHERbiologic sample preservation procedure
approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.
OTHERlaboratory biomarker analysis
Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.
PROCEDUREbiopsy
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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Generation of a biorepository for current and future correlative research studies | Diagnosis, between treatments,7-14 days after start of treatment and at time of definitive therapy |
Countries
United States
Contacts
CONTACTAdrianna Warner
CONTACTErin Kelly
PRINCIPAL_INVESTIGATORLisa A. Carey, MD
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed