NL-OMON52884已完成2 期
A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapy - TIBET
BOOG Study Center0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Adult women(>= 18 years of age) with proven diagnosis of metastatic or
- •locally advanced breast cancer not amenable to curative treatment by surgery or
- •radiotherapy
- •2. Documented ER positive (10%) / PR positive (10%) and HER2 negative
- •metastatic breast cancer
- •3. Progressive disease based on imaging
- •4. Women previously treated with capecitabine (in metastatic setting), and a
- •maximum of two other lines of chemotherapy including a
- •taxane either in the (neo)adjuvant or metastatic setting.
- •5. Evaluable disease as defined per RECIST v.1.1 (see Appendix A). Tumor lesions
- •previously irradiated or subjected to other locoregional therapy will
- •only be deemed
- •measurable if disease progression at the treated site after completion
- •of therapy is
- •clearly documented.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status<= 1
- •7. Life expectancy of >= 12 weeks
- •8. Willing and able to comply with scheduled visits and study procedures
- •9. Adequate organ, bone marrow and coagulation function as shown by:
- •Absolute neutrophil count (ANC) >= 1.5 ×109/L
- •Platelets >= 75 ×109/L
- •Hemoglobin (Hgb) >= 5.6 mmol/L
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=
- •2.5 ULN (or <= 5 if hepatic metastases are present)
- •Total serum bilirubin <= 1.5 × ULN (<= 3 × ULN for patients known to have
- •Gilbert Syndrome)
- •Creatinine clearance >=60 ml/min
- •10. Written informed consent obtained before any screening procedure and
- •according to local guidelines.
- •11. Resolution of all acute toxic effects of prior anti-cancer therapy or
- •surgical procedures to NCI CTCAE version 4.0 Grade <=1, except
- •alopecia or other toxicities not considered a safety risk for the
- •patient at investigator's discretion.
排除标准
- •1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or
- •in situ hybridization positive) and ER-negative patients are not eligible
- •2. No more than two lines of chemotherapy for advanced disease
- •3. Remaining of side-effects from previous chemotherapy > grade 1 (except for
- •4. Radiotherapy within four weeks prior to enrollment is not allowed except in
- •case of localized radiotherapy for analgesic purpose or for lytic lesions at
- •risk of fracture which can then be completed within two weeks prior to
- •enrollment. Patients must have recovered from radiotherapy toxicities prior to
- •enrollment.
- •5. 30% or more marrow-bearing bone being irradiated. Other primary tumors
- •within the last 5 years before study entry are not allowed, except for
- •adequately controlled basal cell carcinoma of the skin, or carcinoma in situ of
- •the cervix.
- •6. Previous or current CNS metastases, carcinomatous meningitis, are not
- •allowed. A CT or MRI of the brain must be performed within 4 weeks prior to
- •registration if the presence of metastases at this site is suspected.
- •7. Evidence of clinically significant cardiovascular or pulmonary disease or
- •any other disease, metabolic or psychological dysfunction, physical examination
- •finding, or clinical laboratory finding giving reasonable suspicion of a
- •disease or condition that contraindicates the use of an investigational drug,
- •or that may affect patient compliance with study routines, or places the
- •patient at high risk from treatment related complications. (e.g lactose
- •intolerance)
- •8. Previously received trifluridine/tipiracil
- •9. Since trifluridine/tipiracil contains lactose, patients with rare hereditary
- •problems of galactose intolerance, the Lapp lactase deficiency or
- •glucose-galactose malabsorption should not take this medicine (see section 4.4
- •of the SmPC). (APPENDIX B)
- •10. Diagnosis of any other malignancy prior to registration, except those that
- •are not believed to influence the patient*s prognosis and do not require any
- •further treatment.
- •11. Other severe acute or chronic medical or psychiatric condition or
- •laboratory abnormality that may increase the risk associated with study
- •participation or investigational product administration or may interfere with
- •the interpretation of study results and, in the judgment of the investigator,
- •would make the patient inappropriate for entry into this study.
研究者
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