NCT00431067已完成2 期
Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 12
- 主要终点
- Objective Response (OR)
研究概览
简要总结
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with confirmed diagnosis of Stage IIIB or IV HER2-positive metastatic breast cancer(HER2 2+ and FISH positive or HER2 3+).
- •Patients must have progressed following receipt of prior standard trastuzumab treatment or standard chemotherapy in conjunction with trastuzumab. Patients with visceral disease or rapid progression should not be included if they have not had previous chemotherapy in addition to trastuzumab. Patients who are intolerant to trastuzumab and who have received adequate chemotherapy and/or hormone therapy are eligible upon progression.
- •Age 18 years or older.
- •Life expectancy of at least four (4) months.
- •Written informed consent that is consistent with ICH-GCP guidelines.
- •Eastern Cooperative Oncology Group (ECOG, R01-0787) performance Score 0, 1 or
- •Patients should not have received treatment with chemotherapy or immune therapy within the last 4 weeks (2 weeks for trastuzumab). Patients should not have received treatment with hormone therapy within the last 2 weeks.
- •Patients must have recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies to CTC less than or equal to Grade
- •Patients must have recovered from previous surgery.
- •Patients must have measurable disease as defined by RECIST criteria.
- •Exclusion criteria:
排除标准
- •Active infectious disease.
- •Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
- •Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
- •Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal MRI scan at screening and be at least three months post-radiation or surgery.
- •Cardiac left ventricular function with resting ejection fraction <50%.
- •Absolute neutrophil count (ANC) less than 1500 cells/mm
- •Platelet count less than 100 000 cells/mm
- •Bilirubin greater than 1.5 mg/dl (>26 micromol /L, SI unit equivalent).
- •Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal.
- •Serum creatinine greater than 1.5 mg/dl (>132 micromol/L, SI unit equivalent).
- •Women and men (and their partners) who are sexually active and unwilling to use a medically acceptable method of contraception.
- •Pregnancy or breast-feeding.
- •Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (including LHRH agonists, or other hormones taken for breast cancer), or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study. Treatment with bisphosphonates is allowed.
- •Prior treatment with an EGFR- or HER2 inhibiting drug (except trastuzumab).
- •Patients unable to comply with the protocol.
- •Active alcohol or drug abuse.
- •Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.
研究组 & 干预措施
BIBW 2992
Experimental
BIBW 2992 (Afatinib) once daily until progression
干预措施: BIBW 2992 (Drug)
结局指标
主要结局
Objective Response (OR)
时间窗: From first dose of study medication to response measurement, up to 34 month
Objective response (OR) including complete response (CR) and partial response (PR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria .
次要结局
- Progression Free Survival (PFS)(From first dose of study medication to the occurrence of progression or death whichever came first, up to 34 month)
- Overall Survival (OS)(From first dose of study medication to death or to the last date the patient was known to be alive, up to 34 month)
- Time to RECIST Tumour Reponse(From first dose of study medication to time when OR measurement was taken.)
- Duration of Confirmed OR(From first OR to time of progression or death)
研究者
研究点 (12)
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Phase II trial of BIBW 2992 in patients with HER2-positive metastatic breast cancer after failure of trastuzumab therapy - Phase II in Trastuzumab FailuresThe medical condition under investigation is HER-2 positive metastatic breast cancer. Patients will have progressed on, or be intolerant of, treatment with trastuzumab (Herceptin).MedDRA version: 9.1Level: PTClassification code 10055113Term: Breast cancer metastaticMedDRA version: 9.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancerEUCTR2007-004805-80-GB40
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