EUCTR2016-002200-39-IT进行中（未招募）1 期
A randomized phase II trial of metronomic oral vinorelbine plus cyclophosphamide and capecitabine (VEX) versus weekly paclitaxel as first or second-line treatment in patients with ER-positive/HER2-negative advanced or metastatic breast cancer - METEORA II
International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 160 人开始时间: 2018年1月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •Histologically or cytologically confirmed HER2-negative locally advanced or metastatic (stage IV) breast cancer.
- •Maximun of one prior line of chemotherapy for advanced or metastatic brest cancer
- •Measurable or non-measurable, but radiologically evaluable (except for skin lesions), disease according to RECIST 1.1 criteria.
- •Female aged 18 years or older.
- •Life expectancy > 3 months.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- •ER-positive disease by local laboratory, determined on most recent available tissue (latest biopsy of metastatic lesion, otherwise prior biopsy or surgical specimen).
- •If previously treated with a taxane in the neoadjuvant or adjuvant setting, the period from end of treatment to disease recurrence must have been > 12 months (> 365 days).
- •Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization.
- •Normal hematologic status,
- •-Absolute neutrophil count =1000/mm3
- •(1.0 × 109/L)
- •-Platelets = 100 × 109/L
- •-Hemoglobin = 9 g/dL (= 90 g/L)).
- •Normal renal function: serum creatinine = 1.5 ULN or calculated creatinine clearance = 50mL/min according to the Cockcroft-Gault formula.
- •Normal liver function:
- •-Serum total bilirubin = 1.5 × upper limit of normal (ULN). In the case of known Gilbert’s syndrome, a higher serum total bilirubin (< 3 × ULN) is allowed
- •-AST and ALT = 3 × ULN; if the patient has liver metastases, ALT and AST must be = 5 × ULN.
- •Women of child bearing potential must have documented negative pregnancy test within 2 weeks prior to randomization and agree to acceptable birth control during and up to 6 months after trial therapy.
- •Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to starting screening procedures and randomization.
- •The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •More than one prior line of chemotherapy for advanced or metastatic breast cancer
- •More than 2 lines of previous endocrine therapy for locally advanced or metastatic breast cancer.
- •Known active central nervous system metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (patients with history of CNS metastases or spinal cord compression are eligible if they are clinically and radiologically stable for at least 4 weeks before first dose of trial treatment and have not required high-dose steroid treatment in the last 4 weeks).
- •Peripheral neuropathy grade 2 or higher (CTCAE version 4.0).
- •Significant uncontrolled cardiac disease (i.e. unstable angina, myocardial infarction within prior 6 months), patients classified as having a New York Heart Association (NYHA) class III or IV congestive heart failure.
- •Pregnant or lactating.
- •Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder).
- •Any concurrent condition which in the Investigator’s opinion makes it inappropriate for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- •Contraindications or known hypersensitivity to the trial medication or excipients.
- •The use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment.
研究者
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