A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: capecitabine [Xeloda]
* Drug: Taxotere
* Drug: Taxotere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients 18-70 years of age; adenocarcinoma of the breast; previous invasive breast cancer if diagnosed >5 years before entering study; no evidence of metastatic disease. Exclusion Criteria: history of severe hypersensitivity reaction to Taxotere; previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane; treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: capecitabine [Xeloda]<br>* 825mg/m2 po bid on days 1-14 of each 3 week cycle<br>Drug: Taxotere<br>* 75mg/m2 iv on day 1 of each 3 week cycle<br>|
| Active Comparator: 2<br> | Drug: Taxotere<br>* 100mg/m2 iv on day 1 of each 3 week cycle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Free Survival [Number of Events] | Number of patients with/without recurrence of breast cancer, or death due to any cause. | 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 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival [Number of Events] | Number of patients who died/were alive. | 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 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 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 . | 
| 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 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 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 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 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 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. |