To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer

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.

Sex

Female

Minimum age

18 Years

Maximum age

70 Years

Inclusion Criteria:

* Females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as T2-3, N0-1, M0 according to the tumor-nodes-metastasis (TNM) classification
* Clinically or radiologically measurable lesion (in 2 dimensions)
* Eastern Cooperative Oncology Group (ECOG) performance Status less than equal to (\<=) 1

Exclusion Criteria:

* Females presenting with brain metastases or a neurological or psychiatric disorder which could interfere with proper treatment compliance
* Previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer
* Previous history of a malignancy in last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix
* Serious concomitant infection
* Pregnant or lactating females