EUCTR2012-003530-16-FR进行中（未招募）1 期
Randomised phase II study evaluating, as first-line chemotherapy, weekly oral vinorelbine as a single-agent versus weekly paclitaxel as a single-agent in estrogen receptor positive, HER2 negative patients with advanced breast cancer.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 124
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
- •· Age superior or equal to 18 years
- •· Histologically confirmed adenocarcinoma of the breast;
- •· Documented locally recurrent or metastatic disease previously untreated by chemotherapy and not amenable to curative surgery or radiotherapy;
- •· Estrogen receptor positive disease determined by superior or equal to 10% positive stained cells for estrogen receptor by immunohistochemistry on the primary tumor or on metastatic site whichever the value of progesterone receptor;
- •· HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH or CISH negative) on the primary tumor or on metastatic site;
- •· Complete staging within 4 weeks prior to randomization;
- •· Must have measurable disease according to RECIST (version 1.1);
- •· Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised;
- •· Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment;
- •· Patients should have received at least one previous hormone therapy for breast cancer in any stage of the disease;
- •· Patients who have received adjuvant or neoadjuvant chemotherapy are allowed if relapsing more than 6 months after the end of chemotherapy;
- •· Patients may have received prior radiotherapy but a minimum of a 4 weeks interval must have elapsed;
- •· Karnofsky Performance Status superior or equal to 70%;
- •· Life expectancy superior or equal to 16 weeks;
- •· Adequate bone marrow, hepatic and renal functions as evidenced by the following:
- •- Haemoglobin superior or equal to 10 g/dL
- •- Absolute Neutrophil Count superior or equal to 1.5 x 109/L
- •- Platelet Count superior or equal to 100 x 109/L
- •- Total Bilirubin inferior or equal to 1.5 x ULN (ULN: Upper Limit of Normal)
- •- SGOT/SGPT inferior or equal to 2.5 x ULN
- •- Alkaline phosphatase < 5 x ULN
- •- Creatinine Clearance > 40 mL/min, calculated using the Cockroft and Gault formula.
- •· Absence of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions should be assessed with the patient before randomization in the trial;
- •· The patient must have access to social insurance if applicable according to the local
- •regulations;
- •· The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- •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 124
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 124
排除标准
- •· Female is not eligible to enter the study if :
- •- pregnant or lactating
- •- with positive pregnancy test at inclusion;
- •· Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
- •· Concomitant hormonal therapy for advanced breast cancer;
- •· Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine;
- •· Prior treatment with chemotherapy in the metastatic setting;
- •· Patients with dysphagia, or inability to swallow the tablets;
- •· Other serious illness or medical conditions:
- •- Clinically significant cardiac disease
- •- Unstable diabetes
- •- Uncontrolled hypercalcemia
- •- Clinically significant active infections (current or in the last two weeks)
- •- Previous organ allograft
- •· Current peripheral neuropathy grade 2 according to NCI version 2 criteria;
- •· Participation in another clinical trial with any investigational drug within 30 days prior to randomization and/or during the study;
- •· History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- •· With known hypersensitivity to vinca alkaloids or taxanes.
研究者
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