XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer

Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery

Pathological complete response was defined as the absence of histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast after 4 cycles of preoperative treatment.

Time frame: at the time of definitive surgery; after four 3-week cycles (3-4 months)

Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))

The best overall response in an individual patient, according to RECIST, during preoperative treatment was the best response recorded from the start of study treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the baseline assessment) or completion of preoperative treatment. Patients with CR or PR were considered responders. Patients with no tumor assessment after the start of study treatment were considered nonresponders.

Time frame: post 2 and 4, 3-week cycles of treatment

Percentage of Participants With Local Recurrence

Local recurrence was defined as evidence of recurrent carcinoma in the same breast where it was diagnosed initially before preoperative treatment.

Time frame: 30 - 1102 days

Participants With Disease-Free Survival

Disease-free survival was defined as the time from date of surgery to date of first evidence of cancer recurrence in the breast (ie, local or distant recurrence or contra lateral disease) or death from any cause, whichever came first. Patients who were alive or withdrawn from the study and had no evidence of disease recurrence and for whom there was CRF evidence that evaluations had been made were censored at the date of the last clinical follow-up assessment when the patient was known to be disease free.

Time frame: 30 - 1102 days

Participants With Overall Survival

Overall survival was defined as the time from date of start of study treatment to the date of death, regardless of the cause of death. Patients who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Patients without follow-up assessment were censored at the day of the last dose. Patients with no post-baseline information were censored at the start of study treatment.

Time frame: 22 - 1191 days