NCT00309556

Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: Austrian Breast & Colorectal Cancer Study Group · Network
• Sex: Female
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Primarily, this clinical investigation compares the rates (percentages) of pathological complete remissions attained at the time of final surgery following 6 cycles each of epirubicin + docetaxel + capecitabine-containing chemotherapy ± trastuzumab (in HER-2 positive disease) vs. epirubicin + docetaxel-containing chemotherapy ± trastuzumab (in HER-2 negative disease).

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Epirubicin	6 cycles 75mg/m2 i.v. day 1 q3w
DRUG	Docetaxel	6 cycles 75mg/m2 i.v. day 1 q3w
DRUG	Capecitabine	6 cycles 1000mg/m2 oral, day 1-14 q2d
DRUG	Trastuzumab	cycle 1: 8mg/kg i.v. day 1 cycle 2-6: 6mg/kg i.v. day 1 (=6 cycles q3w)

Timeline

• Start date: 2005-02-01
• Primary completion: 2009-11-01
• Completion: 2011-11-01
• First posted: 2006-04-03
• Last updated: 2011-12-30

Locations

26 sites across 1 country: Austria