EUCTR2009-014497-18-FR进行中（未招募）1 期
Phase II study evaluating oral vinorelbine as a single agent in patients with hormone receptor breast cancer with bone metastases previously treated by a hormone therapy
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
- 66
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
- •Women with:
- •·Age > or =18 years;
- •·Histologically confirmed adenocarcinoma of the breast;
- •·Documented bone involvement +/- other non visceral metastatic disease previously untreated by chemotherapy;
- •·Hormone receptor positive disease determined by ³10% positive stained cells for oestrogen and/or progesterone receptor by immunohistochemistry on the primary tumor or on metastatic site;
- •·HER2 negative (assessed by 0-1+ IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site;
- •·Complete staging within 4 weeks prior to registration;
- •·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 who have received adjuvant or neoadjuvant chemotherapy are allowed if relapsing more than 6 months after the end of chemotherapy;
- •·Patients should have received at least one hormone therapy for breast cancer in any given previous stage of the disease;
- •·Patients must be under treatment by a bisphosphonate since at least one month before entering the study;
- •·Patients may have received prior radiotherapy but a minimum of a 4 weeks interval must have elapsed;
- •·Karnofsky Performance Status > or = 70%;
- •·Life expectancy > or =16 weeks;
- •·Adequate bone marrow, hepatic and renal functions as evidenced by the following:
- •-Haemoglobin > or = 10 g/dL;
- •-Absolute Neutrophil Count > or =1.5 x 109/L;
- •-Platelet Count > or = 100 x 109/L;
- •-Total Bilirubin < ULN (ULN: Upper Limit of Normal);
- •-SGOT/SGPT < or = 2.5 x ULN,
- •-Alkaline phosphatase < 5 ULN
- •-Creatinine Clearance > 50 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 registration 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Female is not eligible to enter the study if:
- •-pregnant or lactating
- •-with positive pregnancy test at inclusion
- •·Patients with visceral metastatic involvement (that include at least one of the following: liver, lung, pleura, heart, peritoneum, CNS, spleen and suprarenal glands);
- •·Patients with symptoms suggesting CNS involvement or leptomeningeal metastases;
- •·Concomitant hormonal therapy for metastatic 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 (Navelbineâ Oral);
- •·Prior treatment with chemotherapy in the metastatic setting;
- •·Patients previously treated with vinorelbine in the early-stage setting;
- •·Patients with dysphagia, or inability to swallow the tablets;
- •·Other serious illness or medical conditions:
- •-Cardiac disease;
- •-Unstable diabetes;
- •-Uncontrolled hypercalcemia;
- •-Clinically significant active infections;
- •-Previous organ allograft
- •·Current peripheral neuropathy > or = grade 2 according to NCI criteria;
- •·Participation in another clinical trial with any investigational drug within 30 days prior to registration 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
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