EUCTR2009-014497-18-AT进行中（未招募）不适用
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
- 不适用
- 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 >or=10% 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-) or unknown status (exclusively in case of impossibility of testing HER2 status) on the primary tumor or on metastatic site;
- •- 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
研究者
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