Spots Global Cancer Trial Database for Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer

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Trial Identification

Brief Title: Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer

Official Title: A Phase II Neoadjuvant Trial of Sequential Doxorubicin and Docetaxel for the Treatment of Stage III Breast Cancer Measuring STAT Activation as a Predictor of Response to Therapy

Study ID: NCT00005800

Conditions

Breast Cancer

Interventions

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have stage III breast cancer.

Detailed Description: OBJECTIVES: * Evaluate the clinical and pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer. * Measure signal transducer and activator of transcription (STAT) activation before and after this neoadjuvant chemotherapy regimen in this patient population. * Correlate response to chemotherapy with STAT activation before and after this neoadjuvant chemotherapy regimen in these patients. * Determine how other potential predictors of response correlate with STAT activation by measuring Bcl-2, Bcl-xL, Bax protein levels, tyrosine kinase levels, growth rate of the tumor, and apoptotic index before and after this neoadjuvant chemotherapy regimen in these patients. * Correlate response to chemotherapy with levels of STAT activation in association with the presence of Bcl-2 proteins and tyrosine kinases, growth rate of the tumor, and apoptotic index in these patients. * Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense fashion in these patients. OUTLINE: Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses. Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 5 years.