- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00559754
A Study of Avastin (Bevacizumab) and Sequential Chemotherapy in Patients With Primary HER2 Negative Operable Breast Cancer.
2014년 11월 5일 업데이트: Hoffmann-La Roche
An Open Label Study to Assess the Effect of a Combination of Avastin and Docetaxel and Sequential Chemotherapy on Pathological Response in Patients With Primary Operable HER2 Negative Breast Cancer
This single arm study will assess the efficacy and safety of a combination of Avastin and docetaxel following cyclophosphamide and doxorubicin, in patients with HER2 negative operable breast cancer.
Patients will receive 4 x 3 week cycles of chemotherapy with doxorubicin (60mg/m2 iv on day 1 of each cycle) and cyclophosphamide (600mg/m2 iv on day 1 of each cycle).
They will then receive 4 x 3 week cycles of docetaxel (75mg/m2 on day 1 of each cycle) in combination with Avastin (15mg/kg on day 1 of each cycle).
The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
연구 개요
연구 유형
중재적
등록 (실제)
72
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Cordoba, 스페인, 14004
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Jaen, 스페인, 23007
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Lerida, 스페인, 25198
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Malaga, 스페인, 29010
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Zaragoza, 스페인, 50009
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Barcelona
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Sabadell, Barcelona, Barcelona, 스페인, 08208
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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 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
여성
설명
Inclusion Criteria:
- female patients, >=18 years of age;
- primary HER2-negative operable breast cancer;
- tumor >2cm in size;
- ECOG performance status 0-1.
Exclusion Criteria:
- previous treatment for breast cancer;
- metastatic disease;
- current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) or full-dose anticoagulants for therapeutic purposes;
- clinically significant cardiovascular disease.
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)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
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처방대로
각 3주 주기의 제1일에 15mg/kg 정맥주사
각 3주 주기의 제1일에 75mg/m2 iv
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants With Pathological Complete Response (pCR)
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria: 1) the primary tumor was Grade 5 (no malignant cells identified at the location of the primary tumor (ductal carcinoma in situ may be present); 2) no involvement was identified in the lymph nodes; 3) the tumour size at evaluation of the surgical piece was 0 centimeters (cm); and 4) the pathological staging of the tumour from the surgical piece was pT0pN0pM0, the stage is not applicable (NA).
It will only be considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
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After Week 24 (surgery)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Percentage of Participants With Objective Clinical Response
기간: Within 28 days of enrollment, Weeks 12 and 24
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Overall clinical response is the best response obtained through physical examination and/or radiological tests after completion of chemotherapy cycles.
The percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) and was categorized as clinical response (CR+PR) or clinical benefit (CR+PR+ no change [NC]).
Per RECIST, CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level.
PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) of all target lesions.
No unequivocal progression of non-target disease.
No new lesions.
Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.
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Within 28 days of enrollment, Weeks 12 and 24
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Percentage of Participants With Breast-Conserving Surgery
기간: Week 24
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Breast-conserving surgery was defined as lumpectomy + lymphadenectomy (LA), segmentectomy + LA, quadrantectomy + LA, or other (including sentinal node extirpation tumorectomy).
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Week 24
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Percentage of Participants With pCR by Proliferation of Ki67
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
Biomarker Ki67 proliferation was defined as low (less than [<]15% ) and high (≥15%).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Kisspeptin (KISS1) Amplification
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
KISS1 amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by KISS1 Protein Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
KISS1 protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Vascular Endothelial Growth Factor Receptor (VEGFR) Amplification
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEFGR amplification was defined as 1 (aneuploid), 2 (normal), 4 (amplification), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by VEGFR Protein Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEGFR protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Hypoxia Inducible Factor (HIF) Protein Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
HIF protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Endothelial Nitric Oxide Synthase (ENOS) Protein Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
ENOS protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Angiotension Protein Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
Angiotensin protein expression was defined as 0 (no expression), 1 (normal), 2 (augmented expression), or NE (not evaluated).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Vascular Endothelial Growth Factor (VEGF) Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by VEGFR Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
VEGFR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Phosphorylated AKT (pAKT) Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
pAKT gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by HIF Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
HIF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Insulin-Like Growth Factor (IGF) Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
IGF gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by ENOS Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
ENOS gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Phosphorylated MAP Kinase (pMAPK) Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
pMAPK gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by Angiotensin II Receptor Type I (AGTR) Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
AGTR gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by KISS1 Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
KISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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Percentage of Participants With pCR by RKISS1 Gene Expression
기간: After Week 24 (surgery)
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The percentage of participants with pCR was determined by anatomopathological study after completion of 8 cycles of study treatment.
The anatomopathological study of the surgical piece was performed and assessed according to the Miller-Payne criteria.
It was only considered pCR in the case of absence of invasive tumour cells in the breast and lymph nodes.
RKISS1 gene expression was defined as below the housekeeping reference level (>0), above the housekeeping reference level (<0), or equal to the housekeeping reference level (0).
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After Week 24 (surgery)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 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
2007년 12월 1일
기본 완료 (실제)
2010년 9월 1일
연구 완료 (실제)
2010년 9월 1일
연구 등록 날짜
최초 제출
2007년 11월 15일
QC 기준을 충족하는 최초 제출
2007년 11월 15일
처음 게시됨 (추정)
2007년 11월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 11월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 11월 5일
마지막으로 확인됨
2014년 11월 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. .
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