Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
UNC Lineberger Comprehensive Cancer Center
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 r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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, live…
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.
Location
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina