ISRCTN79877830已完成2 期
Phase II multicentre study assessing the efficacy of Cabazitaxel in Patients with HER2-negative metastatic breast cancer and having unresectable brain metastases (CiPHER)
The Clatterbridge Cancer Centre NHS Foundation Trust (UK)0 个研究点目标入组 19 人开始时间: 2013年6月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 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
入排标准
- 性别
- Female
入选标准
- •First or second line metastatic HER2 negative* breast cancer
- •1. Oligometastatic brain disease that is unsuitable for surgical resection and/or stereotactic radiosurgery
- •2. Age 18 years or over
- •3. ECOG performance status 0-2
- •4. Diagnosis of metastatic HER2-negative breast cancer
- •5. 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.
- •6. Females of child bearing potential who have a negative pregnancy test prior to study entry
- •7. Agree to use adequate contraception which they agree to continue for 12 months after the study treatment
- •8. Ability and capacity to comply with study and follow-up procedure
- •9. 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.
排除标准
- •1. Received prior radiotherapy/radiosurgery to the brain (radiotherapy may be offered on disease progression)
- •2. Received >2 lines of chemotherapy for metastatic recurrent disease (adjuvant treatment is permitted) prior to registration
- •3. Received any chemotherapy after the diagnosis of brain metastases
- •4. Previous hormone therapy if it will not be discontinued before Cabazitaxel treatment
- •5. 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)
- •6. Visceral metastases with no recorded brain metastases
- •7. Pregnancy or lactation
- •8. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 28 days prior to registration
- •9. Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
- •10. Grade =2 peripheral motor and/or sensory neuropathy
- •11. Grade =2 mucositis oral
- •12. History of severe hypersensitivity reaction (=grade 3) to taxanes
- •13. History of severe hypersensitivity reaction (=grade 3) to polysorbate 80-containing drugs
- •14. Other concurrent serious illness or medical conditions which make it undesirable for the patient to enter the trial (including uncontrolled diabetes mellitus)
- •15. Inadequate organ and bone marrow function as evidenced by:
- •15.1. Haemoglobin < 9.0 g/dL
- •15.2. Absolute neutrophil count < 1.5 x 109/L
- •15.3. Platelet count <100 x 109/L
- •15.4. AST/SGOT and/or ALT/SGPT >2.5 x ULN
- •15.5. total bilirubin >1.0 x ULN
- •15.6. 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
- •16. Active infection requiring systemic antibiotic or anti ? fungal medication.
- •17. Participation in another clinical trial with any investigational drug within 30 days prior to registration
- •18. 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
- •19. Concomitant vaccination with live attenuated vaccines
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