Clinical trial NCT00089479: A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-08-06
Enrollment: 2611
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Disease Free Survival [Number of Events]
timeFrame: 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.
measure: Disease Free Survival [Time to Event]
timeFrame: 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 outcomes:
measure: Overall Survival [Number of Events]
timeFrame: 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.
measure: Overall Survival [Time to Event]
timeFrame: 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.
measure: Breast Cancer Free Survival [Number of Events]
timeFrame: 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 .
measure: Breast Cancer Free Survival [Time to Event]
timeFrame: 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.
measure: Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
timeFrame: 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.
measure: Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
timeFrame: 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.
measure: Disease Free Survival Including Any New Cancer as Event [Number of Events]
timeFrame: 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.
measure: Disease Free Survival Including Any New Cancer as Event [Time to Event]
timeFrame: 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.
Other outcomes:
Locations:
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.