- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00620100
To Determine the Objective Response Rate of 4 Cycles of Docetaxel + Anthracycline (Epirubicin or Doxorubicine) Followed by 4 Cycles of Docetaxel Single Agent
2009년 5월 29일 업데이트: Sanofi
A Multicenter, Open Label, Phase II Trial Evaluating Docetaxel (Taxotere®) + Anthracycline (Epirubicin or Doxorubicin) x 4 Cycles Followed by Docetaxel (T) Single Agent x 4 Cycles as First-Line Therapy in Patients With Her2 Negative Locally Advanced or Metastatic Breast Cancer Who Have Relapsed > or = 12 Months From Completion of Neoadjuvant/Adjuvant Taxotere®-Based Chemotherapy
To determine the Objective Response Rate of 4 cycles of docetaxel + anthracycline (epirubicin or doxorubicine) followed by 4 cycles of docetaxel single agent.
To determine the Time to Tumor Progression (TTP), the Response Duration, the Overall Survival.
To confirm the safety profile
연구 개요
연구 유형
중재적
등록 (실제)
2
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- Female patient with histologically or cytologically documented breast adenocarcinoma
- First local or metastatic relapse
- Patients must have received a prior neoadjuvant or adjuvant Taxotere®-based chemotherapy regimen, provided this chemotherapy was completed > than or = to 12 months prior to enrollment date
- Prior hormone or immune therapy is allowed. Antitumoral adjuvant hormone therapy may be continued during the study period, provided it was started > 12 months prior to study enrollment
- Her2/neu negative tumor demonstrated by immunohistochemistry (IHC 0 or 1+) or by fluorescence in situ hybridation (FISH -). A patient with tumor assessed as 2+ by IHC can be enrolled if the tumor is negative by FISH.
- ECOG performance status of 0 to 2
- Normal cardiac function confirmed by LVEF or shortening fraction (MUGA scan or echocardiography, respectively, within normal limits for the institution) assessed within 3 months prior to study entry. An ECG must be obtained within 4 weeks prior study entry and must demonstrate no clinically significant abnormality.
- Patients are required to have at least one measurable lesion according to RECIST guidelines
Adequate organ function defined by:
- Hematology: Neutrophils > than or = to 2.0 109/L, Platelets > than or = to 100 109/L, Hemoglobin > than or = to 10 g/dL
- Hepatic function: Total bilirubin within normal limits, AST (SGOT) and ALT (SGPT) < than or = to 1.5 UNL, alkaline phosphatase < than or = to 2.5 UNL (unless accompanied by extensive bone metastases)
- Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential
- Written informed consent prior to beginning specific protocol procedures must be obtained and documented according to the local regulatory requirements
Exclusion Criteria
- Prior therapy for advanced or recurrent disease
- Previous cumulative exposure to epirubicin > 600 mg/m² or to doxorubicin > 300 mg/m²
- Previous radiation therapy having involved more than 25% of bone marrow; incomplete recovery from toxicity of radiation therapy
- Symptomatic brain metastases and clinically diagnosed leptomeningeal metastases
- Isolated unmeasurable bone lesions, serous pleural effusion or pulmonary lymphangiitis (i.e., unmeasurable disease according to the RECIST guidelines)
- Pre-existing motor or sensory neurologic toxicity of a severity > than or = to grade 2 according to NCI-CTC AE criteria version 3.0
- Pregnant or lactating women or women of childbearing potential not using adequate contraception
Other serious illness or medical conditions, including:
- Congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
- History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would hamper understanding and giving informed consent.
- Active uncontrolled infection
- Active peptic ulcer, uncontrolled diabetes mellitus
Past or current history of neoplasm other than breast carcinoma, except:
- Curatively treated non-melanoma skin cancer.
- in situ carcinoma of the cervix.
- Other cancer curatively treated and with no evidence of disease for at least 10 years
- Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (< than or = to 20 mg methylprednisolone per day or equivalent)
- Definite contraindications for the use of corticosteroids
- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
- Concurrent treatment with other investigational drugs. Active treatment as part of another clinical therapeutic trial within 30 days prior to study entry
- Concurrent treatment with any other anti-cancer therapy, except adjuvant hormone therapy started > than or = to 12 months prior to study enrollment. Bisphosphonates for management of bone metastases or osteoporosis/osteopenia are allowed
- History of hypersensitivity to docetaxel (or drugs formulated in polysorbate 80), epirubicin or doxorubicin
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Evaluate the objective response rate according to RECIST guidelines after treatment with Taxoterer and anthracycline followed by Taxoterer single agent in the first line treatment of Her2 negative locally advanced or metastatic breast cancer
기간: During the study conduct
|
During the study conduct
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
To evaluate the Time to Tumor Progression (TTP).
기간: During the study conduct
|
During the study conduct
|
To evaluate the response duration.
기간: During all the study conduct
|
During all the study conduct
|
To evaluate the overall survival.
기간: During the study conduct
|
During the study conduct
|
To confirm the safety profile.
기간: from the inform consent signed up to the end of the study
|
from the inform consent signed up to the end of the study
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Véronique AGNETTI, Sanofi
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
2004년 9월 1일
기본 완료 (실제)
2005년 4월 1일
연구 완료 (실제)
2005년 4월 1일
연구 등록 날짜
최초 제출
2008년 2월 11일
QC 기준을 충족하는 최초 제출
2008년 2월 20일
처음 게시됨 (추정)
2008년 2월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 5월 29일
마지막으로 확인됨
2009년 5월 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. .
유방 신생물에 대한 임상 시험
도세탁셀에 대한 임상 시험
-
Hebei Medical University Fourth Hospital완전한