NCT01000883

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1998-12-01
• Primary completion: 2030-11-01
• Completion: 2032-11-01
• First posted: 2009-10-23
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States