A Randomised Phase 2 Study of Neoadjuvant Docetaxel and Cyclophosphamide Compared to Doxorubicin and Cyclophosphamide in Operable Node Negative Breast Cancer With Normal Topoisomerase IIα Expression
- 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
- 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
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Pathological complete response rate
Wong Nan Soon, MBBS, MRCP, FAMS
National Cancer Centre, Singapore