EUCTR2012-000542-35-GB进行中（未招募）1 期
Phase II multicentre study assessing the efficacy of Cabazitaxel in Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases. - CiPHER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
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
- All
入选标准
- •First or second line metastatic HER2 negative* breast cancer
- •Oligometastatic brain disease that is unsuitable for surgical resection and/or stereotactic radiosurgery
- •Age =18 years
- •ECOG performance status 0-2
- •Diagnosis of metastatic HER2-negative breast cancer
- •At least one measurable target lesion (RECIST 1.0) in the brain (unsuitable for resection) identified by CT scan or MRI within 21 days of registration.
- •Females of child bearing potential who have a negative pregnancy test prior to study entry
- •Agree to use adequate contraception which they agree to continue for 12 months after the study treatment
- •Ability and capacity to comply with study and follow-up procedure
- •Able to provide written informed consent
- •Patients with ER+ve or ER-ve disease are eligible for the study
- •Patients with meningeal disease are eligible provided they fit the other criteria. Extracranial disease is not a requirement of this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Received prior radiotherapy/radiosurgery to the brain (radiotherapy may be offered on disease progression)
- •Received >2 lines of chemotherapy for metastatic recurrent disease (adjuvant treatment is permitted) prior to registration
- •Received any chemotherapy after the diagnosis of brain metastases
- •Previous hormone therapy if it will not be discontinued before Cabazitaxel treatment
- •Patients who have received an increasing dose of steroids to control CNS symptoms within 14 days of registration (steroid use is permitted only when patient is stable at a specific dose at the time of screening)
- •Visceral metastases with no recorded brain metastases
- •Pregnancy or lactation
- •Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 28 days prior to registration
- •Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
- •Grade =2 peripheral motor and/or sensory neuropathy
- •Grade =2 mucositis oral
- •History of severe hypersensitivity reaction (=grade 3) to taxanes
- •History of severe hypersensitivity reaction (=grade 3) to polysorbate 80-containing drugs
- •Other concurrent serious illness or medical conditions which make it undesirable for the patient to enter the trial (including uncontrolled diabetes mellitus)
- •Inadequate organ and bone marrow function as evidenced by:
- •g.Haemoglobin < 9.0 g/dL
- •h.Absolute neutrophil count < 1.5 x 109/L,
- •i.Platelet count <100 x 109/L,
- •j.AST/SGOT and/or ALT/SGPT >2.5 x ULN;
- •k.total bilirubin >1.0 x ULN,
- •l.Serum creatinine >1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded (18). See Appendix B
- •Active infection requiring systemic antibiotic or anti – fungal medication.
- •Participation in another clinical trial with any investigational drug within 30 days prior to registration
- •Administration of potent inhibitors and inducers of P450 3A4/5 enzymes within 7 days of registration, or planned concurrent administration whilst on study. This excludes steroid treatment which is standard care treatment for patients with brain metastases
- •Concomitant vaccination with live attenuated vaccines
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