PER-049-03已完成未知
RANDOMIZED PHASE III COMPARATIVE TRIAL OF VINORELBIN AGAINST THE ASSOCIATION OF GEMCITABIN AND VINORELBIN IN PATIENTS WITH ADVANCED BREAST CARCINOMA PREVIOUSLY TREATED WITH ANTRACYCLINICS AND TAXANES.
试验速览
- 阶段
- 未知
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •[1] Patients with stage IV breast carcinoma or histologically confirmed disseminated disease (the primary tumor), with evaluable disease.
- •[2] Histological or cytological diagnosis of breast cancer, with evidence of metastatic disease. The lesions will not be susceptible to curative treatment through surgery and / or radiotherapy.
- •[3] Women over 18 years old.
- •[4] Previous chemotherapy with anthracyclines and taxanes.
- •[5] Having received a maximum of two previous treatments with chemotherapy for the disseminated disease
- •[6] Prior radiotherapy will be authorized, as long as the irradiated area does not constitutes the only disease documentation.
排除标准
- •[1] Active infection or serious concomitant disease (at the investigator´s discretion).
- •[2] Clinical evidence of metastasis in the central nervous system (CNS).
- •[3] Blastic bony lesions as the only documentation of disease.
- •[4] Previous neurological toxicity grade 3-4.
- •[5] Previous treatment with gemcitabine and / or vinorelbine.
- •[6] More than two previous treatments with chemotherapy for metastatic disease.
- •[7] Altered liver function (bilirubin> 2.0 times above normal value); ALT and AST> 2.5 times higher than the normal range. ALT and AST can be raised 5 times above the normal value in patients with known liver metastases.
- •[8] Inadequate renal function (creatinine> 2.0 mg / dL).
- •[9] Pregnancy or lactation period.
研究者
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