NCT00425854已完成2 期
An Open Label Phase II Trial to Assess the Efficacy and Safety of a Once Daily Oral Dose of 50 mg BIBW 2992 in Two Cohorts of Patients With HER2-negative Metastatic Breast Cancer After Failure of no More Than Two Chemotherapy Regimen
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
- 50
- 试验地点
- 14
- 主要终点
- Objective Response (OR)
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients age 18 years or older
- •Histologically proven breast cancer after failure or relapse of no more than three lines of chemotherapy including adjuvant, irrespective of prior hormone therapy metastatic disease (stage IV);
- •HER2-negative patients (HER2 1+ or negative, or HER2 2+ and FISH negative)
- •At least one measurable tumour lesion (RECIST);
- •Availability of tumour samples
- •Written informed consent that is consistent with ICH-GCP guidelines and local law
- •Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 -
- •Exclusion criteria:
排除标准
- •Active infectious disease
- •Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhoea
- •Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol
- •Active/symptomatic brain metastases
- •Cardiac left ventricular function with resting ejection fraction < 50% (below upper limit of normal)
- •ANC less than 1500/mm3 platelet count less than 100 000/mm3
- •Bilirubin greater than 1.5 mg /dl (>26 and#61549 mol /L, SI unit equivalent)
- •AST and ALT greater than 2.5 times the upper limit of normal or greater 5 times the upper limit of normal in case of known liver metastases
- •Serum creatinine greater than 1.5 mg/dl (>132 and#61549 mol/L, SI unit equivalent)
- •Patients who are sexually active and unwilling to use a medically acceptable method of contraception
- •Pregnancy or breast-feeding
- •Concomitant treatment with other investigational drugs or other anti-cancer-therapy during this study and/or during the past two/four weeks, prior to the first treatment with the trial drug. Concurrent treatment with biphosphonates is allowed
- •Previous treatment with trastuzumab, EGFR-, or EGFR/HER2-inhibitors patients unable to comply with the protocol
- •Active alcohol or drug abuse
- •Other malignancy within the past 5 years
研究组 & 干预措施
BIBW 2992
Experimental
high dose once daily
干预措施: BIBW 2992 (Drug)
结局指标
主要结局
Objective Response (OR)
时间窗: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
OR is defined as complete response (CR) and partial response (PR) and was assessed according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST). OR was primary endpoint only for Cohort B.
Clinical Benefit (CB)
时间窗: Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.
CB was defined as CR, PR or stable disease (SD) for a minimum of 4 months (modified CB) and was assessed according to RECIST 1.0 criteria. CB was primary endpoint only for Cohort A.
次要结局
- Overall Survival (OS)(From randomisation to end of follow-up.)
- Best Change From Baseline in ECOG Performance Status(baseline till end of treatment)
- Clinical Benefit (CB)(Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.)
- Significant Change in Cardiac Left Ventricular Ejection Fraction (LVEF)(Baseline and last assessment)
- Time to OR(Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.)
- Duration of OR(Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.)
- Progression-free Survival (PFS)(Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.)
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 29 (Cpre,ss,29)(day 29)
研究者
研究点 (14)
Loading locations...
相似试验
招募中
2 期
Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment FailuresCTRI/2011/07/001915Boehringer Ingelheim Pharmaceuticals120
终止
2 期
Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.NeoplasmsNCT00748709Boehringer Ingelheim20
已完成
2 期
Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC PatientsCarcinoma, Non-Small-Cell LungNCT00730925Boehringer Ingelheim41
已完成
2 期
Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-TProstate CancerNCT01174368The Rogosin Institute1
已完成
2 期
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or TrastuzumabBreast NeoplasmsNCT00826267Boehringer Ingelheim29