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

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.

Conditions

• Breast Cancer

Interventions

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

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Indiana University School of Medicine

  collaborator OTHER

• Walther Cancer Institute

  collaborator OTHER

• Hoosier Cancer Research Network

  lead OTHER

Principal Investigators

• Kathy Miller, M.D. · Hoosier Oncology Group, LLC

• George Sledge, M.D. · Hoosier Oncology Group, LLC

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-09-30

Primary Completion

2010-12-31

Completion

2010-12-31

Countries

• United States
• Peru

Study Locations