This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,611
Unnamed facility
Houston, Texas, United States
Disease Free Survival [Number of Events]
Number of patients with/without recurrence of breast cancer, or death due to any cause.
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival [Time to Event]
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Overall Survival [Number of Events]
Number of patients who died/were alive.
Time frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Overall Survival [Time to Event]
Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.
Time frame: Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.
Breast Cancer Free Survival [Number of Events]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
Time frame: Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .
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Breast Cancer Free Survival [Time to Event]
Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time frame: Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Number of Events]
Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.
Disease Free Survival Including Any New Cancer as Event [Time to Event]
Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.