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
- Evaluate the clinical and pathological response rate of sequential doxorubicin and
docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pathological Response Rate
Evaluate the pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer. Pathologic response is classified as either complete pathologic response or partial pathologic response based on the size of residual tumor after treatment (complete pathologic response if 0 cm, partial pathologic response if >0 cm).
Susan Minton, D.O.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|