EUCTR2007-006078-27-DE进行中（未招募）不适用
A PHASE 2, TWO-ARM, DOUBLE-BLIND, MULTICENTER, RANDOMIZEDSTUDY OF THE COMBINATION OF ORAL WX-671 PLUS CAPECITABINE VS.CAPECITABINE MONOTHERAPY IN FIRST-LINE HER2-NEGATIVEMETASTATIC BREAST CANCER
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Wilex AG
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1)Females aged = 18 years.
- •2)Patients appropriate for palliative first-line, mono chemotherapy with capecitabine
- •3)Histological or cytological confirmed, non-inflammatory metastatic breast cancer
- •4)Availability of paraffin-embedded tumor tissue from the primary resection or biopsy of a metastatic lesion.
- •5)HER2-negative breast cancer (as per immunohistochemistry DAKO score 0 1; DAKO score 2 and negative FISH assay; all negative FISH assays).
- •6)Complete staging within 2 weeks prior to randomization (4 weeks for bone scan).
- •7)Radiologically confirmed disease: at least one measurable lesion according to RECIST-patients with bone metastases only are allowed
- •8)ECOG (Eastern Cooperative Oncology Group) performance status of = 2.
- •9)Ability to understand and willingness to voluntarily sign and date a written informed consent form before screening, following an explanation of the nature and purpose of this study.
- •10)Negative pregnancy test (urine or serum) within 3 days before first study drug for women of childbearing potential. Effective contraception must be used by women of childbearing potential during the study and for 3 months after stopping study drug treatment.
- •11)Normal organ and marrow function as defined by laboratory parameters (obtained within the screening period) within the following limits:
- •neutrophils >= 1.5 x 109/L;
- •platelets >= 100 x 109/L;
- •hemoglobin >= 9.0 g/dL (5.6 mmol/L).
- •Note: Patients may receive blood transfusions as medically appropriate during the study. Patients who require a blood transfusion during screening must have stable hemoglobin (= 9.0 g/dL) without the need for further transfusions during the 2 weeks before first dose of study medication in order to remain eligible;
- •total bilirubin <= 1.5 x upper limit of normal (ULN);
- •aspartate aminotransferase (AST)/ALT <= 2.5 x ULN (<= 5.0 x ULN for patients with liver metastases);
- •serum creatinine <= 2 x ULN, or calculated creatinine clearance >45 mL/min according to Cockroft and Gault formula).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1)Endocrine therapy completed within 2 weeks before the start of treatment (i.e. previous hormone therapy is allowed provided that there is a washout period of 2 weeks).
- •2)Prior chemotherapy or biologic therapy for metastatic disease.
- •3)Major surgery within 4 weeks prior to the start of treatment.
- •4)Other anti-cancer treatment (e.g. hormones) within 2 weeks before the start of treatment.
- •5)Treatment within 12 months with adjuvant 5-FU containing chemotherapy (regarded as indicating 5-FU resistance) and/or prior capecitabine therapy.
- •6)Radiation therapy for the metastatic disease. Palliative radiation of stable, non-target lesions more than 2 weeks before the start of treatment is allowed, provided patients have recovered from the radiation side-effects.
- •7)History of or radiological evidence of brain metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement.
- •8)Active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months.
- •9)History of other malignancy within the last 3 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
- •10)Active cardiac disease e.g. unstable angina, congestive heart failure, myocardial infarction (MI) within the preceding 6 months.
- •11)Any medical condition prohibiting standard imaging procedures
- •12)Pregnant or breast-feeding.
- •13)Any unrelated illness, e.g. active infection requiring parenteral antibiotics, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect patients’ study participation.
- •14)Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of either study drug.
- •15)Known hepatitis B/C or HIV (human immunodeficiency virus) infection.
研究者
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