NL-OMON34674已完成3 期
X-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment - LUX-Breast 1
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- female patients, older than 18;
- •- Histologically confirmed diagnosis of HER2 overexpression breast cancer;
- •- Stage 4 metastatic disease;
- •- Progressed on one prior trastuzumab treatment, but not received and failed on more than 1 trastuzumab based treatment;
- •- Patient must have received anthracycline and/or taxane based chemotherapy for adjavant treatment or first line treatment;
- •- Must have (archived) tumour tissue sample available for central re-assessment of HER2 status and prove HER2 positive;
- •- Must have at least one measurable lesion according to the RECIST criteria;
- •- Must have an ECOG score of 0 or 1;
- •- Must have a life expectancy of at least 6 months.
排除标准
- •- Prior treatment with EGFR/HER2 targeted small molecules or antibodies other than trastuzumab;
- •- Prior treatment with vinorelbine;
- •- Known pre-existing interstitial lung disease;
- •- Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation;
- •- Active brain metastases;
- •- Any other current malignancy or malignancy diagnosed within the last 5 years;
- •- Significant or recent acute gastro-intestinal disorders;
- •- History or presence of clinically relevant cardiovascular abnormalities;
- •- Cardiac left ventricular function with less than 50%.
研究者
相似试验
进行中（未招募）
1 期
Afatinib (BIBW 2992) in HER2 Overexpressing Metastatic Breast Cancer Patientspatients with metastatic HER2 over-expressing breast cancerMedDRA version: 16.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-015476-98-GBBoehringer Ingelheim Limited745
进行中（未招募）
1 期
X-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment - LUX-Breast 1patients with metastatic HER2 over-expressing breast cancerMedDRA version: 12.1Level: LLTClassification code 10057654Term: Breast cancer femaleMedDRA version: 12.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerMedDRA version: 12.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2009-015476-98-FRBOEHRINGER INGELHEIM FRANCE780
进行中（未招募）
不适用
X-Breast 1; An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment - LUX-Breast 1patients with metastatic HER2 over-expressing breast cancerMedDRA version: 12.1Level: LLTClassification code 10057654Term: Breast cancer femaleMedDRA version: 12.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerMedDRA version: 12.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2009-015476-98-FIBoehringer Ingelheim780
进行中（未招募）
1 期
Afatinib (BIBW 2992) in HER2 Overexpressing Metastatic Breast Cancer Patientspatients with metastatic HER2 over-expressing breast cancerMedDRA version: 16.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-015476-98-CZBoehringer Ingelheim RCV GmbH & Co KG780
进行中（未招募）
1 期
Afatinib (BIBW 2992) in HER2 Overexpressing Metastatic Breast Cancer Patientspatients with metastatic HER2 over-expressing breast cancerMedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-015476-98-NLBoehringer Ingelheim780