Finding studies
Finding studies
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Lead
National Cancer Centre, Singapore
OBJECTIVES: Primary * To evaluate tumor pathological complete response rate after neoadjuvant cyclophosphamide in combination with docetaxel vs doxorubicin hydrochloride in women with operable clinically node-negative breast cancer and normal topoisomerase IIα expression. Secondary * To assess tumor clinical and pathological overall response rates in patients treated with these regimens. * To assess the safety and toxicity of these regimens. * To assess disease-free survival and overall survival of these patients. * To assess the efficacy of short-course (3 days) filgrastim (G-CSF) as primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide. OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor \[ER\]- or progesterone receptor \[PR\]-positive vs ER- and PR-negative) and T stage (T2 vs T3). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive cyclophosphamide IV and docetaxel IV over 1 hour on day 1. * Arm II: Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. In both arms, treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of neoadjuvant chemotherapy, all patients undergo surgery. Tumor specimens obtained prior to neoadjuvant chemotherapy are analyzed for topoisomerase IIα gene and protein expression by IHC and FISH. Tissue samples are also collected at surgery for future studies. After completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Age
21–any
Sex
FEMALE
Healthy volunteers
Not accepted
