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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00089479
First received: August 5, 2004
Last updated: December 19, 2012
Last verified: December 2012

August 5, 2004
December 19, 2012
August 2002
June 2010   (final data collection date for primary outcome measure)
  • Disease Free Survival [Number of Events] [ 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. ] [ Designated as safety issue: No ]
    Number of patients with/without recurrence of breast cancer, or death due to any cause.
  • Disease Free Survival [Time to Event] [ 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. ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT00089479 on ClinicalTrials.gov Archive Site
  • Overall Survival [Number of Events] [ 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. ] [ Designated as safety issue: No ]
    Number of patients who died/were alive.
  • Overall Survival [Time to Event] [ 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. ] [ Designated as safety issue: No ]
    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.
  • Breast Cancer Free Survival [Number of Events] [ 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 . ] [ Designated as safety issue: No ]
    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.
  • Breast Cancer Free Survival [Time to Event] [ 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. ] [ Designated as safety issue: No ]
    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.
  • Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events] [ 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. ] [ Designated as safety issue: No ]
    Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
  • Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event [ 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. ] [ Designated as safety issue: No ]
    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.
  • Disease Free Survival Including Any New Cancer as Event [Number of Events] [ 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. ] [ Designated as safety issue: Yes ]
    Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
  • Disease Free Survival Including Any New Cancer as Event [Time to Event] [ 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. ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Not Provided
Not Provided
 
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: capecitabine [Xeloda]
    825mg/m2 po bid on days 1-14 of each 3 week cycle
  • Drug: Taxotere
    75mg/m2 iv on day 1 of each 3 week cycle
  • Drug: Taxotere
    100mg/m2 iv on day 1 of each 3 week cycle
  • Experimental: 1
    Interventions:
    • Drug: capecitabine [Xeloda]
    • Drug: Taxotere
  • Active Comparator: 2
    Intervention: Drug: Taxotere
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2611
May 2012
June 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00089479
NO17629
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP