A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
2012년 12월 19일 업데이트: Hoffmann-La Roche
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.
연구 개요
연구 유형
중재적
등록 (실제)
2611
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Texas
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Houston, Texas, 미국, 77060
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
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각 3주 주기의 1-14일에 825mg/m2 po 입찰
각 3주 주기의 제1일에 75mg/m2 iv
100mg/m2 iv on day 1 of each 3 week cycle
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활성 비교기: 2
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각 3주 주기의 제1일에 75mg/m2 iv
100mg/m2 iv on day 1 of each 3 week cycle
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Disease Free Survival [Number of Events]
기간: 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.
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Number of patients with/without recurrence of breast cancer, or death due to any cause.
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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.
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Disease Free Survival [Time to Event]
기간: 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.
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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.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Survival [Number of Events]
기간: 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.
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Number of patients who died/were alive.
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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.
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Overall Survival [Time to Event]
기간: 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.
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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.
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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.
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Breast Cancer Free Survival [Number of Events]
기간: 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 .
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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.
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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 .
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Breast Cancer Free Survival [Time to Event]
기간: 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.
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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.
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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.
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Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]
기간: 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.
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Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
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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.
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Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event
기간: 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.
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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.
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Disease Free Survival Including Any New Cancer as Event [Number of Events]
기간: 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.
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Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
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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.
|
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Disease Free Survival Including Any New Cancer as Event [Time to Event]
기간: 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.
|
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.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2002년 8월 1일
기본 완료 (실제)
2010년 6월 1일
연구 완료 (실제)
2012년 5월 1일
연구 등록 날짜
최초 제출
2004년 8월 5일
QC 기준을 충족하는 최초 제출
2004년 8월 5일
처음 게시됨 (추정)
2004년 8월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 12월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 12월 19일
마지막으로 확인됨
2012년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .