A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer

Breast Cancer Clinical Trial

Official title: Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01

Status Terminated

Clinical Trial Summary

The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.

Clinical Trial Description

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 ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00235235
• Study type: Observational
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: N/A
• Start date: September 2005
• Completion date: December 2010