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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00089479
• Other study ID #: NO17629
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2004
• Last updated: December 19, 2012
• Start date: August 2002
• Est. completion date: May 2012

Study information

• Verified date: December 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2611
• Est. completion date: May 2012
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine [Xeloda]
825mg/m2 po bid on days 1-14 of each 3 week cycle
• Taxotere
75mg/m2 iv on day 1 of each 3 week cycle
• Taxotere
100mg/m2 iv on day 1 of each 3 week cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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 .	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	Yes
Secondary	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.	Yes