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Completed

NCT Number: NCT00089479

A Study of Xeloda (Capecitabine) in Women 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Houston, Texas, 77060, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

capecitabine [Xeloda]

Drug

825mg/m2 po bid on days 1-14 of each 3 week cycle

Taxotere

Drug

75mg/m2 iv on day 1 of each 3 week cycle

Primary outcomes

  1. 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.

    Number of patients with/without recurrence of breast cancer, or death due to any cause.

  2. 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.

    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 outcomes

  1. 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.

    Number of patients who died/were alive.

  2. 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.

    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.

  3. 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 .

    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.

  4. 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.

    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.

  5. 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.

    Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.

  6. 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.

    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.

  7. 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.

    Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.

  8. 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.

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2010
Study completion
2012
First posted
Aug 6, 2004
Registry last updated
Dec 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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