Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
2016년 6월 17일 업데이트: Boehringer Ingelheim
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
The general aim of this study is to investigate the efficacy and safety of afatinib alone and in combination with weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, locally advanced or metastatic inflammatory breast cancer.
The study will include patients who have and have not failed prior trastuzumab treatment.
연구 개요
연구 유형
중재적
등록 (실제)
26
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Seoul, 대한민국
- 1200.89.82001 Boehringer Ingelheim Investigational Site
-
Seoul, 대한민국
- 1200.89.82002 Boehringer Ingelheim Investigational Site
-
-
-
-
California
-
Los Angeles, California, 미국
- 1200.89.10001 Boehringer Ingelheim Investigational Site
-
-
North Carolina
-
Durham, North Carolina, 미국
- 1200.89.10005 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Bournemouth, 영국
- 1200.89.44002 Boehringer Ingelheim Investigational Site
-
London, 영국
- 1200.89.44001 Boehringer Ingelheim Investigational Site
-
London, 영국
- 1200.89.44003 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Bangkok, 태국
- 1200.89.66002 Boehringer Ingelheim Investigational Site
-
Bangkok, 태국
- 1200.89.66004 Boehringer Ingelheim Investigational Site
-
Chiangmai, 태국
- 1200.89.66003 Boehringer Ingelheim Investigational Site
-
Hat-Yai, Songkhla, 태국
- 1200.89.66001 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Ariana, 튀니지
- 1200.89.21601 Boehringer Ingelheim Investigational Site
-
Sousse, 튀니지
- 1200.89.21602 Boehringer Ingelheim Investigational Site
-
-
-
-
Victoria
-
East Bentleigh, Victoria, 호주
- 1200.89.61002 Boehringer Ingelheim Investigational Site
-
-
Western Australia
-
Perth, Western Australia, 호주
- 1200.89.61003 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Hong Kong, 홍콩
- 1200.89.85201 Boehringer Ingelheim Investigational Site
-
-
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 with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Locally advanced or metastatic disease
- Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
- For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
- Investigator-confirmed diagnosis of Inflammatory Breast Cancer
- Must have biopsiable disease
Exclusion criteria:
- Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
- Must not have received prior vinorelbine treatment
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Afatinib once daily (OD)
Patients receive afatinib monotherapy once daily until progression of their disease
|
Patient to receive afatinib monotherapy until progression of their disease
Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
기간: This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
|
This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
|
Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
기간: This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered).
|
This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
기간: This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
|
Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
기간: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.
|
|
Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
기간: This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.
|
|
Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
기간: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
|
This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.
|
|
Part A: Duration of Unconfirmed Objective Response.
기간: From first drug administration until end of Part A, up to 929 days.
|
Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR).
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)).
|
From first drug administration until end of Part A, up to 929 days.
|
|
Part B: Duration of Unconfirmed Objective Response.
기간: From first drug administration until end of Part B, up to 929 days.
|
Objective response was defined on a patient level as a best response of CR or PR.
Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS).
|
From first drug administration until end of Part B, up to 929 days.
|
|
Part A: Progression Free Survival.
기간: From first drug administration until end of Part A, up to 713 days.
|
PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study A.
|
From first drug administration until end of Part A, up to 713 days.
|
|
Part B: Progression Free Survival.
기간: From first drug administration until end of Part B, up to 230 days.
|
PD was evaluated according to the RECIST version 1.1.
For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1.
The date of progression and date of first administration referred to the respective part of the study B.
|
From first drug administration until end of Part B, up to 230 days.
|
|
Progression Free Survival Over the Whole Sudy.
기간: From first drug administration until end of study, up to 700 days.
|
PD was evaluated according to the RECIST version 1.1.
Number of days from the start of monotherapy to the date of second PD.
|
From first drug administration until end of study, up to 700 days.
|
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.
유용한 링크
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
2011년 8월 1일
기본 완료 (실제)
2014년 11월 1일
연구 완료 (실제)
2014년 11월 1일
연구 등록 날짜
최초 제출
2011년 3월 28일
QC 기준을 충족하는 최초 제출
2011년 3월 28일
처음 게시됨 (추정)
2011년 3월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 7월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 6월 17일
마지막으로 확인됨
2016년 6월 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. .