EUCTR2016-002674-12-ES进行中（未招募）1 期
A phase II, randomised, opened and multicenter study, to evaluate the effect of metronomic oral Vinorelbine vs the best treatment of support as maintenance therapy after first-line chemotherapy based on taxanes in patients with breast cancer HER-2 negative resistant to endocrine therapy.
Asociación Terapéutica Investigación Oncológica (ATRIO)0 个研究点目标入组 125 人开始时间: 2016年9月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 125
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
入选标准
- •1. Having voluntarily given informed consent before performing the specific assay procedures.
- •2. Women aged =18 years.
- •3. MMC (stage IV) and HER2 negative histologically determined in the local laboratory. HER2 negative must have been determined by immunohistochemistry (IHC) or in situ hybridization when the HER2 / CEP17 ratio is <2 or when the average HER2 gene copies is <4 signals per cell.
- •4. Pre-treatment with first-line chemotherapy based on taxanes. The first line chemotherapy may have included any approved taxane (docetaxel, paclitaxel or nab-paclitaxel) as a single agent or in a combination regimen with other cytotoxic agents, bevacizumab or other antidiana drugs. The patient must have received at least 4 cycles (12 weeks) of taxane chemotherapy regimen. There is no maximum number of cycles of taxane induction to be receiving the patient.
- •5. It should be considered a minimum period of 4 weeks and a maximum of 6 weeks after completion of treatment with taxanes to the inclusion of the patient in the study
- •6. Measurable disease or evaluable unmeasurable disease according to RECIST version 1.1, at the start of first-line chemotherapy based on taxanes without evidence of progression disease (RECIST version 1.1) at the time of inclusion. Patients must have achieved an objective response (CR or PR) or SD.
- •7. Patients with positive HR must meet the criterion of resistance to endocrine therapy (criteria Advanced Breast Cancer Second International Consensus Conference ABC2 for primary or secondary resistance) consisting of:
- •to. Progression to prior endocrine therapy for metastatic disease (without limiting the number of lines of endocrine therapy alone or combined with drugs antidiana).
- •b. Relapse during the neo / adjuvant or during the first year after completion of the same endocrine therapy.
- •8. Patients may have received neoadjuvant or adjuvant treatment after surgery of the primary tumor, whenever more than 6 months have elapsed between the administration of the last dose of neo / adjuvant chemotherapy and the first-line chemotherapy for metastatic disease.
- •9. ECOG performance status of 0 or 1.
- •10. Recovery of any toxicity to grade =1 pretreatment according to the criteria of the NCI-CTCAE version 4.0 at the time of the inclusion of the patient, with the exception of peripheral neuropathy.
- •11. Adequate organ function during the 7 days prior to administration of the first dose of treatment, defined as:
- •to. absolute neutrophil count (ANC) =1.500 cells / ul.
- •b. Hemoglobin =9 g / dL; transfusion being allowed to achieve these levels of hemoglobin.
- •c. =100.000 platelet cells / ul.
- •d. Serum creatinine =1,5 ??x upper limit of normal (ULN).
- •and. ALT and AST =5xLSN =2.5xLSN or if the presence of liver metastases. =1.5xLSN total serum bilirubin, except in patients with Gilbert's syndrome, for those in which bilirubin should be within the normal range.
- •12. Life expectancy of at least 12 weeks.
- •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 100
- •F.1.3 Elderly (>=65
排除标准
- •1. Patients who have received more than one line of chemotherapy for metastatic disease.
- •2. Patients who have received first-line chemotherapy without taxanes for metastatic disease.
- •3. Patients with positive HR with hormone sensitivity criteria that:
- •a. They have not received prior treatment for in metastatic disease with endocrine therapy.
- •b. They have gone to a neo / adjuvant endocrine therapy after more than 12 months of completion.
- •4. Not measurable or evaluable disease at the start of chemotherapy in first-line.
- •5. Progression disease during first-line taxane-based chemotherapy.
- •6. Inclusion of the patient beyond 6 weeks of completion of treatment with taxanes.
- •7. Unavailability of the evaluation of tumor response after the last cycle taxane chemotherapy administered.
- •8. Intention to maintain treatment with bevacizumab or any other antidiana agent during the study.
- •9. Active antineoplastic treatment within 42 days prior to randomization
- •(Except treatment with taxane ± another drug in combination as an anthracycline).
- •10. Brain metastases or leptomeningeal metastasis. performing a CT for checking the presence of these lesions is not necessary, except clinically suspected disease in the central nervous system (CNS) by the investigator.
- •11. Pregnant women, breast feeding or with a positive pregnancy test in the visit in the selection period; Women of childbearing potential and sexually active are unwilling to use adequate contraception (such as oral contraceptives, intrauterine device or method of contraceptive barrier with spermicide or surgical sterilization) during the study and up to 3 months after administration of the last dose of study treatment.
- •12. Use of any drug / investigational product or participation in another clinical trial simultaneously or within 28 days prior to randomization.
- •13. Peripheral neuropathy grade> 2 according to the criteria of the NCI-CTCAE version 4.0.
- •14. Previous radiation therapy in =30% of bone marrow or termination thereof or without full recovery of toxicities that may have experienced during radiation therapy given 30 days prior.
- •15. Patients with the diagnosis of other malignancies during the 5 years prior to inclusion in the study, despite having been adequately treated (except non-melanoma skin cancer and in situ cervical or colon carcinoma, adequately treated).
- •16. Any uncontrolled systemic disease such as heart disease, lung disease or clinically significant metabolic disease, severe infection, etc.
- •17. Inability to swallow tablets or reduction prior history of stomach or small intestine, or gastrointestinal absorption disorders that may interfere with the oral administration of the treatment under study.
- •18.- hereditary fructose intolerance.
- •19. Known hypersensitivity to study drug or other drugs of similar chemical structure.
- •20. Patients requiring treatment with strong inhibitors or inducers of CYP3A4 such as ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampin or phenytoin, etc. (Annex 4).
- •21. Any major surgery or significant traumatic injury within 28 days prior to randomization, or for
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