A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
2015년 2월 26일 업데이트: Hoffmann-La Roche
'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'
This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression.
The anticipated time on study treatment is 3-12 months.
연구 개요
연구 유형
중재적
등록 (실제)
69
단계
- 2 단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Madrid, 스페인, 28027
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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:
- women 18-70 years of age;
- metastatic or locally advanced breast cancer;
- HER2 overexpression;
- >= 1 measurable lesion.
Exclusion Criteria:
- prior treatment for advanced breast cancer;
- prior treatment with Herceptin;
- bone or central nervous system metastasis as the only site of disease;
- history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.
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: Trastuzumab, Myocet, Paclitaxel; Phase I
Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression.
Participants also received myocet, 40 mg/ square meter (m^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles.
Participants also received paclitaxel 60 mg/ m^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
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Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
다른 이름들:
60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression
40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles
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실험적: Trastuzumab, Myocet, Paclitaxel; Phase II
Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression.
Participants also received myocet, 50 mg/m^2, IV, every 3 weeks, from Week 1 for 6 cycles.
Participants also received paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
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Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
다른 이름들:
60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression
40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment
기간: Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion.
For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.
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Baseline (BL), Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time to Disease Progression - Percentage of Participants With an Event
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause.
For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (>)2 square centimeters (cm^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2.
For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Disease Progression
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from the start of treatment to disease progression event.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Treatment Response - Percentage of Participants With an Event
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Treatment Response
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from the start of treatment to treatment response event.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Duration of Response - Percentage of Participants With an Event
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted.
For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of >2 cm^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm^2, an increase of ≥1 cm^2.
For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Duration of Response
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from enrollment to duration of response event to Week 52.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Therapy Failure - Percentage of Participants With an Event
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent.
Participants were censored at the last dose of treatment if no event was recorded.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Time to Therapy Failure
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The median time, in months, from treatment start to therapy failure event.
Participants were censored at the last date of treatment if no event was recorded.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Overall Survival (OS) - Percentage of Participants With an Event
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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Overall Survival
기간: BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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The time, in months, from the start of treatment to OS event.
The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.
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BL, Weeks 7, 13, 19, every 8 weeks thereafter until end of study (for up to 3 years)
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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
2001년 7월 1일
기본 완료 (실제)
2009년 9월 1일
연구 완료 (실제)
2009년 9월 1일
연구 등록 날짜
최초 제출
2013년 12월 3일
QC 기준을 충족하는 최초 제출
2013년 12월 13일
처음 게시됨 (추정)
2013년 12월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 3월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 2월 26일
마지막으로 확인됨
2015년 2월 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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Society for Endocrinology초대로 등록
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trastuzumab에 대한 임상 시험
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UNICANCER아직 모집하지 않음신생물 전이 | 삼중 음성 유방 신생물 | HER 2 저발현 유방암프랑스
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Memorial Sloan Kettering Cancer CenterAstraZeneca모병
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Fundación Pública Andaluza para la Investigación...모병유방암 | 전이성 유방암 | 약물 관련 부작용 및 부작용 | Pharmacogenetic Variant스페인
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Fudan University아직 모집하지 않음HER2 양성 유방암 | 뇌 전이가 있는 유방암
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Kristina A. FanucciStemline Therapeutics, Inc.모병유방암 | 전이성 유방암 | 유방암 여성 | HER2 음성 유방암 | HER2 낮은 유방 암종미국
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Shanghai Henlius Biotech완전한
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Sun Yat-sen University아직 모집하지 않음진행성/전이성 유방암 | HER2+、저발현 또는 초저발현 진행성/전이성 유방암중국