The purpose of this study is to learn if the biomarker information obtained (learned or received) from the earlier studies can tell researchers whether or not Taxotere (docetaxel) and/or Adriamycin (doxorubicin hydrochloride)/Cytoxan (cyclophosphamide) can cause tumors to become smaller.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00206518.
PRIMARY OBJECTIVES:
I. To assess clinical tumor response to neoadjuvant chemotherapy (Taxotere and Adriamycin/ Cytoxan [AC]) and to validate that clinical response strongly correlates with prospectively-determined regimen-specific gene expression profiles of sensitivity and resistance.
SECONDARY OBJECTIVES:
I. To determine time to tumor progression.
II. Median overall survival.
III. Document toxicities associated with the chemotherapy regimens in the Neoadjuvant setting and document toxicities associated with the chemotherapy regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive docetaxel intravenously (IV) over 1-2 hours once every 21 days. Neoadjuvant treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical removal or the tumor or the entire breast followed by AC therapy comprising doxorubicin hydrochloride IV over 1-2 hours and cyclophosphamide IV over 1-2 hours once every 21 days. Adjuvant treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive AC therapy as in Arm A. Neoadjuvant treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgical removal or the tumor or the entire breast followed by docetaxel IV as in Arm A. Adjuvant treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorMothaffar Fahed Rimawi
