LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
2019년 3월 15일 업데이트: Boehringer Ingelheim
LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting
The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
74
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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Taichung, 대만, 404
- China Medical University Hospital
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Taichung, 대만, 40705
- Taichung Veterans General Hospital
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Taipei, 대만, 100
- National Taiwan University Hospital
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Taipei, 대만, 10449
- Mackay Memorial Hospital
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Taipei, 대만, 112
- Taipe Veterans General Hospital
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Taipei, 대만, 112
- Koo Foundation Sun Yet-Sen Cancer Center
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Kazan, 러시아 연방, 420029
- St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
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Krasnodar, 러시아 연방, 350040
- Clinical Oncology Dispensary No. 1, Dept. Chemotherapy
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Moscow, 러시아 연방, 129128
- N.A. Semashko Central Clinical Hospital, Moscow
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Pyatigorsk, 러시아 연방, 357502
- SBIH of Stavropol territory "Pyatigorsk Oncol. Dispensary"
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Samara, 러시아 연방, 443 031
- SBIH "Samara Regional Clinical Oncol. Dispensary", Samara
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Sochi, 러시아 연방, 354057
- GUZ "Oncological Dispesary #2"
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Stavropol, 러시아 연방, 355 047
- Stavropol Regional Clin. Oncology Dispensary Dept. Oncology
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Yaroslavl, 러시아 연방, 150 040
- Yaroslavl Regional Clinical Oncology Hosp. Dept.Chemotherapy
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Barnstaple, 영국, EX31 4JB
- North Devon District Hospital
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Bournemouth, 영국, BH7 7DW
- Royal Bournemouth and Christchurch Hospital
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Exeter, 영국, EX2 5DW
- Royal Devon and Exeter Hospital
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London, 영국, W6 8RF
- Charing Cross Hospital
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Amravati, 인도, 444606
- Sujan Surgical Cancer Hospital
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Maharashtra, 인도, 422 004
- Curie Manavata Cancer Centre
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Maharashtra, 인도, 400 012
- Tata Memorial Hospital
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Nagpur, 인도, 440010
- Central India Cancer Research Institute
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Pune, 인도, 411001
- Ruby Hall Clinic
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Thiruvananthapuram, 인도, 695 011
- Regional Cancer Center
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Gdansk, 폴란드, 80-211
- University Clinical Center, Gdansk
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Hong Kong, 홍콩
- Queen Mary Hospital
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Shatin, 홍콩
- Prince of Wales Hospital
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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 with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
- Stage IV metastatic disease
- At least one measurable lesion according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1). Skin, bone and brain lesions are considered non-target lesions
- Must have failed or progressed on either trastuzumab or lapatinib or trastuzumab and lapatinib treatment in the neoadjuvant and/or adjuvant setting
Exclusion criteria:
- Prior first line therapy for metastatic breast cancer
- Known pre-existing interstitial lung disease
- Active brain metastases
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to trial treatment.
- Cardiac left ventricular function with resting ejection fraction of less than 50%.
- Prior treatment with Epidermal Growth Factor Receptor (EGFR)/HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
- Prior treatment with paclitaxel in the past 12 months
- Must not have received prior vinorelbine treatment - Further exclusion criteria apply
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: Afatinib 40mg once daily (OD)
Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
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Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
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실험적: Paclitaxel 80 mg/m2 weekly
Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
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Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
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실험적: Vinorelbine 25 mg/m2 weekly
Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
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Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
기간: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Objective response according to RECIST v1.1.
Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented.
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From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Best Overall Response According to RECIST v1.1 (With Confirmation)
기간: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented.
Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT).
As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
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From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)
기간: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented.
Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT).
As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
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From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Progression Free Survival (PFS)
기간: From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
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Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'.
Median is calculated from the Kaplan-Meier curve.
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From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression
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Duration of Objective Response According to RECIST v1.1
기간: From the first objective response to the time of progression or death, up to 1562 days
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Duration of objective response, defined as the time from first objective response to the time of progression or death.
(regardless of confirmation).
As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.
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From the first objective response to the time of progression or death, up to 1562 days
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Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher
기간: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher.
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From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)
기간: Baseline and End of treatment period, up to 1562 days
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Change from baseline to end of treatment in systolic blood pressure (SBP).
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Baseline and End of treatment period, up to 1562 days
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Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)
기간: Baseline and End of treatment period, up to 1562 days
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Change from baseline to end of treatment in diastolic blood pressure (DBP).
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Baseline and End of treatment period, up to 1562 days
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Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values
기간: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates).
Acronyms Used: Prothrombin time-International normalized ratio (PT-INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT)
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From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days
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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 (실제)
2011년 5월 24일
기본 완료 (실제)
2017년 3월 13일
연구 완료 (실제)
2017년 3월 13일
연구 등록 날짜
최초 제출
2011년 1월 6일
QC 기준을 충족하는 최초 제출
2011년 1월 6일
처음 게시됨 (추정)
2011년 1월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 15일
마지막으로 확인됨
2019년 3월 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. .