NCT00235235

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

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
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Biopsy	core biopsy
PROCEDURE	Serum Collection	serum collection
PROCEDURE	Urine Collection	urine collection
DRUG	Doxorubicin	Doxorubicin 60 mg/m2 day 1 of every 21-day cycle
DRUG	Cyclophosphamide	Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
DRUG	Capecitabine	Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle
DRUG	Vinorelbine	Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle
DRUG	Gemcitabine	Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

Timeline

• Start date: 2005-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2005-10-10
• Last updated: 2015-12-09

Locations

11 sites across 2 countries: United States, Peru