EUCTR2009-011118-47-ES进行中（未招募）不适用
Ensayo clínico en fase III de vinflunina IV frente a un agente alquilante en pacientes con cáncer de mama metastásico previamente tratado con o resistente a una antraciclina, un taxano, un antimetabolito y un alcaloide de la vincaPhase III trial of IV vinflunine versus an alkylating agent in patients with metastatic breast cancer previously treated with or resistant to an anthracycline, a taxane, an antimetabolite, and a vinca-alkaloid (study L00070 IN 308 B0)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 586
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
- •1. Patients must give written informed consent (personally signed and dated) before completing any study-related procedure
- •2. Women with histologically or cytologically confirmed carcinoma of the breast
- •3. Documented metastatic disease not amenable to curative surgery or radiotherapy
- •4. Patients must have received at least two and no more than five prior chemotherapy regimens given for the treatment of locally recurrent and/or metastatic disease, excluding chemotherapy received in the neo/adjuvant setting
- •5. Prior treatments must have included an anthracycline, a taxane, an antimetabolite and a vinca-alkaloid (except vinflunine) in any combination or order
- •Patients may have received ixabepilone in countries where the drug has been registered.
- •6. Patients must be no longer candidate for anthracycline, taxane, antimetabolite and vinca-alkaloïd (except vinflunine) due to at least one of the following reasons:
- •- resistance to the drug defined as disease progression while on therapy or progression within 4 months of receiving last dose in the metastatic setting.
- •Only for anthracycline and taxane, a patient will also be considered as resistant if she relapsed within 12 months of last dose when given in the adjuvant or neoadjuvant setting.
- •- intolerance to the drug defined as the occurrence of severe myelotoxicity (febrile neutropenia, neutropenic infection, grade 4 neutropenia requiring G-CSF support, grade 4 thrombocytopenia or grade 3 thrombocytopenia requiring platelet transfusion) and/or the occurrence of grade ? 3 non-haematological toxicity and / or the occurrence of grade 2 non-haematological toxicity lasting 14 days or more during one cycle of the drug,
- •- only for anthracycline, minimum cumulative dose of 180 mg/m2 for doxorubicin or 300 mg/m2 for epirubicin.
- •7. Patients must have received their last dose of vinca-alkaloid more than 4 months before randomisation
- •8. Patients may have been treated with anti-cancer hormonal therapy but are no longer considered candidate for hormone therapy
- •9. Patients with Her-2 positive tumours may have been treated with anti-Her 2 targeted therapy (trastuzumab, lapatinib) and must have discontinued at least 4 weeks prior to randomisation
- •10. Prior radiation therapy is allowed and must be completed at least 4 weeks before randomisation
- •11. Measurable or non measurable disease
- •12. Estimated life expectancy > or = 12 weeks
- •13. WHO performance status < or = 2
- •14. Age > or = 18 years and < or = 75 years
- •15. Adequate haematological function : absolute neutrophil count (ANC) >or = 1.5 x 109/l, platelets >or = 100 x 109/L, haemoglobin >or = 10g/dl
- •16. Adequate hepatic function : transaminases 17. Adequate renal function : creatinine or = 50 ml/min
- •18. Women of childbearing potential must be using a medically accepted method of contraception (barrier methods, intrauterine devices) 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 first treatment administration
- •19. The patient must have access to social insurance
排除标准
- •1. Patients with pulmonary lymphangitis or symptomatic pleural effusion (grade >or = 2) that results in pulmonary dysfunction requiring active treatment
- •2. Patients with meningeal carcinomatosis
- •3. Patients with central nervous system metastases unless the patient has completed local therapy, is stable for at least 4 weeks by CT-scan without evidence of cerebral oedema and has no requirement for corticosteroids or anticonvulsivants
- •4. Patients having received any other experimental or anti-cancer therapy within 30 days before randomisation except hormone therapy
- •5. Patients who participated in a prior vinflunine clinical trial
- •6. History of second primary malignancy, except bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, and other malignancy treated at least 5 years previously with no evidence of recurrence
- •7. Patients with pre-existing motor/sensory peripheral neuropathy of CTCAE version 3.0 grade > 1
- •8. History of severe hypersensitivity to vinca-alkaloids and/or alkylating agents or any contra indication to the study drugs
- •9. Known history of HIV infection
- •10. Pregnant or breast feeding women
- •11. Patients who have any serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation
- •12. Prior history of high-dose chemotherapy with bone marrow transplantation or autologous stem cell infusion
研究者
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