Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01
OUTLINE: This is a 4 arm, multi-center study.
Sample Collection:
- Core Biopsy
- Serum
- Urine
Treatment Regimens (Investigator/Patient Discretion):
- Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
- Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
- Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
- Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle
Performance status & Organ Function:
Performance status and organ function appropriate for chemotherapy in the opinion of the
treating investigator according to Good Clinical Practice (GCP).
Life Expectancy: Not specified
Hematopoietic: Not specified
Hepatic: Not specified
Renal: Not specified
Cardiovascular: Not specified
Pulmonary: Not specified
Observational
Time Perspective: Prospective
To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer
36 months
No
Kathy Miller, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Institutional Review Board
HOG COE-01
NCT00235235
September 2005
December 2010
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Center for Cancer Care at Goshen Health System | Goshen, Indiana 46526 |
Arnett Cancer Care | Lafayette, Indiana 47904 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Community Regional Cancer Center | Indianapolis, Indiana 46256 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Mary Lou Mayer, M.D. | Indianapolis, Indiana 46227 |
Baylor College of Medicine - Methodist Breast Center | Houston, Texas 77030 |