Conditions: Breast Cancer
Keywords: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 51
Healthy volunteers: no

Brief summary:
The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Detailed description:
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Arms:
arm 1: Docetaxel will be given at 100mg/m\^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks). arm 2: Docetaxel will be given at 50mg/m\^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Interventions: intervention 1: Docetaxel intervention 2: Capecitabine
Intervention descriptions: intervention 1: Sequential Therapy: Docetaxel will be given at 100 mg/m\^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles.

Concurrent Therapy: Docetaxel will be given at 50 mg/m\^2 IV Day 1. intervention 2: Sequential Therapy: administration of capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Protocol document: