이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

2015년 8월 21일 업데이트: Hoffmann-La Roche

A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.

This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

424

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 러시아 연방
      • Kazan, 러시아 연방, 420029
      • Moscow, 러시아 연방, 115478
      • Obninsk, 러시아 연방, 249036
      • Ryazan, 러시아 연방, 390011
      • Saint-Petersburg, 러시아 연방, 197758
      • UFA, 러시아 연방, 450054
  • 루마니아
      • Bucharest, 루마니아, 050098
      • Bucuresti, 루마니아, 022328
      • Cluj Napoca, 루마니아, 400015
      • Cluj-Napoca, 루마니아, 400015
      • Iasi, 루마니아, 700106
  • 멕시코
      • Acapulco, 멕시코, 39850
      • Guadalajara, 멕시코, 45100
      • Merida, 멕시코, 97500
      • Monterrey, 멕시코, 66260
      • Torreon, 멕시코, 27000
  • 보스니아 헤르체고비나
      • Banja Luka, 보스니아 헤르체고비나, 78000
      • Sarajevo, 보스니아 헤르체고비나, 71000
      • Tuzla, 보스니아 헤르체고비나, 75000
  • 브라질
    • GO
      • Goiania, GO, 브라질, 74605-070
    • RS
      • Porto Alegre, RS, 브라질, 90610-000
    • SC
      • Florianopolis, SC, 브라질, 88034-000
    • SP
      • Barretos, SP, 브라질, 14784-400
      • Sao Paulo, SP, 브라질, 01509-010
  • 스페인
      • Barcelona, 스페인, 08003
      • Cordoba, 스페인, 14004
      • Madrid, 스페인, 28046
      • Zaragoza, 스페인, 50009
    • Barcelona
      • Sabadell, Barcelona, Barcelona, 스페인, 08208
  • 아르헨티나
      • Buenos Aires, 아르헨티나, 1417
      • Cordoba, 아르헨티나, 5004
      • La Plata, 아르헨티나, B1902CMK
      • Mar del Plata, 아르헨티나, 7600
      • Mendoza, 아르헨티나, 5500
      • Salta, 아르헨티나, 4400
      • San Martin, 아르헨티나, 1650
      • Santa Fe, 아르헨티나, 2000
      • Santa Fe, 아르헨티나, 03000
  • 영국
      • Exeter, 영국, EX2 5DW
      • London, 영국, SE1 7EH
      • Manchester, 영국, M20 4BX
      • Nottingham, 영국, NG5 1PB
      • Preston, 영국, PR2 9HT
      • Rhyl, 영국, LL18 5UJ
      • Stoke-on-Trent, 영국, ST4 6QG
      • Weston Super Mare, 영국, BS23 4TQ
  • 오스트리아
      • Graz, 오스트리아, 8036
      • Salzburg, 오스트리아, 5020
      • Vöcklabruck, 오스트리아, 4840
      • Wien, 오스트리아, 1090
  • 우루과이
      • Montevideo, 우루과이, 11600
      • Montevideo, 우루과이, 11200
  • 이탈리아
    • Emilia-Romagna
      • Parma, Emilia-Romagna, 이탈리아, 43100
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, 이탈리아, 33100
    • Lombardia
      • Milano, Lombardia, 이탈리아, 20133
      • Pavia, Lombardia, 이탈리아, 27100
  • 체코 공화국
      • Praha 2, 체코 공화국, 128 08
      • Praha 5, 체코 공화국, 150 06
  • 칠면조
      • Izmir, 칠면조, 35100
      • Sıhhiye, ANKARA, 칠면조, 06100
  • 캐나다
      • Quebec, 캐나다, G1S 4L8
    • Alberta
      • Calgary, Alberta, 캐나다, T2N 4N2
    • British Columbia
      • Vancouver, British Columbia, 캐나다, V5Z 4E6
    • Nova Scotia
      • Halifax, Nova Scotia, 캐나다, B3H 1V7
    • Ontario
      • Hamilton, Ontario, 캐나다, L8V 5C2
      • Sudbury, Ontario, 캐나다, P3E 5J1
      • Toronto, Ontario, 캐나다, M4N 3M5
    • Quebec
      • Montreal, Quebec, 캐나다, H3A 1A1
      • Montreal, Quebec, 캐나다, H3T 1E2
      • Montreal, Quebec, 캐나다, H2W 1S6
    • Saskatchewan
      • Saskatoon, Saskatchewan, 캐나다, S7N 4H4
  • 프랑스
      • Avignon, 프랑스, 84918
      • Besancon, 프랑스, 25030
      • Bordeaux, 프랑스, 33076
      • Caen, 프랑스, 14076
      • Clermont Ferrand, 프랑스, 63011
      • Dijon, 프랑스, 21079
      • Lille, 프랑스, 59020
      • Montpellier, 프랑스, 34298
      • Villejuif, 프랑스, 94805
  • 호주
    • New South Wales
      • Lismore, New South Wales, 호주, 2480
      • Newcastle, New South Wales, 호주, 2298
      • Port Macquarie, New South Wales, 호주, 2444
      • Wahroonga, New South Wales, 호주, 2076
      • Wollongong, New South Wales, 호주, 2500
    • Queensland
      • Auchenflower, Queensland, 호주, 4066
      • Nambour, Queensland, 호주, 4560
    • Victoria
      • Fitzroy, Victoria, 호주, 3065
      • Geelong, Victoria, 호주, 3220
    • Western Australia
      • Perth, Western Australia, 호주, 6000

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

모두

설명

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • HER2 positive breast cancer with locally recurrent or metastatic lesions;
  • eligible for chemotherapy;
  • baseline LVEF >=50%.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
  • other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
  • clinically significant cardiovascular disease;
  • chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 1
의약품: 베바시주맙[아바스틴]
3주마다 15mg/kg 정맥주사
의약품: Docetaxel
100mg/m2 iv every 3 weeks
의약품: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
활성 비교기: 2
의약품: Docetaxel
100mg/m2 iv every 3 weeks
의약품: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Survival (OS)
기간: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline
기간: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter [LD] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Duration of Response (DR)
기간: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Time to Treatment Failure (TTF)
기간: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
기간: Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
Change From Baseline for FACT-G and FACT-B
기간: Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hoffmann-La Roche

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2006년 9월 1일

기본 완료 (실제)

2014년 8월 1일

연구 완료 (실제)

2014년 8월 1일

연구 등록 날짜

최초 제출

2006년 10월 20일

QC 기준을 충족하는 최초 제출

2006년 10월 20일

처음 게시됨 (추정)

2006년 10월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 8월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 8월 21일

마지막으로 확인됨

2015년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • BO20231

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. .

구독하다