EUCTR2009-014497-18-IT进行中（未招募）不适用
Phase II study evaluating oral vinorelbine as a single agent in patients with hormone receptor positive breast cancer with bone metastases previously treated by a hormone therapy. - ND
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 >/= 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 >/=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-) 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 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 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 >/= 70%; Life expectancy >/= 16 weeks; Adequate bone marrow, hepatic and renal functions as evidenced by the following: -Haemoglobin >/= 10 g/dL; -Absolute Neutrophil Count >/= 1.5 x 109/L; -Platelet Count >/= 100 x 109/L; -Total Bilirubin < ULN (ULN: Upper Limit of Normal); -SGOT/SGPT 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 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 (Navelbine 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 >/= 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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