A Randomized Phase III Study Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF to Epirubicin and Docetaxel + G-CSF as Neoadjuvant Treatment for Early HER-2 Negative Breast Cancer and Comparing Epirubicin, Docetaxel and Capecitabine + G-CSF ± Trastuzumab to Epirubicin and Docetaxel + G-CSF ± Trastuzumab as Neoadjuvant Treatment for Early HER-2 Positive Breast Cancer
This study is a prospective, randomized, multicentre, phase III trial in the neoadjuvant
treatment of patients with primary breast cancer and no distant metastases. Patients will be
stratified at inclusion according to the centre, to the clinical tumour stage (T1, T2, T3,
T4a-c), the axillary lymph node status (positive, negative), the menopausal status
(pre-menopausal, post-menopausal), histology (invasive ductal, invasive lobular, mixed), the
hormone-receptor status (positive [ER+/PR+, ER+/PR-, ER-/PR+], negative [ER-/PR-], not
determinable]), the HER-2 status (positive, negative, not determinable), the grading (G1/G2,
G3, not determinable) and will be randomly assigned to receive either 6 cycles of
neoadjuvant epirubicin, docetaxel and capecitabine ± trastuzumab in HER-2 positive disease
or 6 cycles of neoadjuvant epirubicin and docetaxel ± trastuzumab in HER-2 positive disease.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of pathological complete remissions
at the time of final surgery after 6 cycles of Arm A (Epirubicin/ Docetaxel/ Capecitabine-containing chemotherapy ± Trastuzumab in HER-2 positive disease) vs. Arm B (Epirubicin/Docetaxel-containing chemotherapy ± Trastuzumab in HER-2 positive disease).
20 weeks
No
Guenther Steger, MD
Study Chair
Austrian Breast & Colorectal Cancer Study Group
Austria: Federal Office for Safety in Health Care
ABCSG-24
NCT00309556
February 2005
November 2011
Name | Location |
---|