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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: capecitabine [Xeloda]
Drug: Taxotere
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2611
Study Start Date: August 2002
Study Completion Date: May 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 Drug: Taxotere
100mg/m2 iv on day 1 of each 3 week cycle

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089479

Locations
United States, Texas
Houston, Texas, United States, 77060
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00089479     History of Changes
Other Study ID Numbers: NO17629
Study First Received: August 5, 2004
Results First Received: March 31, 2011
Last Updated: December 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Docetaxel
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 29, 2014