To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the efficacy and safety of treatment with oral capecitabine or
intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide,
prior to surgery in participants with breast cancer. The participants will receive 4 cycles
of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin +
Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85).
After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast
surgery with regional lymph node dissection will be performed, followed within a maximum of 6
weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study
arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m^2) by
IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period,
participants will enter the post-treatment follow-up period which will last for 5 years from
the initial date of participant randomization. During this period participants will be
evaluated once a year on the anniversary date of randomization.