2024-519204-27-00进行中（未招募）2 期
A phase 2 study of trifluridine/tipiracil in patients with ER-positive, HER2-negative advanced breast cancer that previously received chemotherapy (BOOG 2019-01 TIBET study)
BOOG Study Center B.V.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with a taxane and capecitabine
研究概览
简要总结
To evaluate the efficacy of trifluridine/tipiracil by determination of the percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with 2 or 3 lines of chemotherapy including taxane and for metastatic breast cancer capecitabine
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Documented ER positive (10%) and/or PR positive (10%) and HER2 negative metastatic breast cancer
- •Progressive disease based on imaging
- •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.
- •Evaluable disease as defined per RECIST v.1.
- •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.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Life expectancy of ≥ 12 weeks
- •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
- •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
- •HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive) and ER-negative patients are not eligible
- •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.
- •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.
- •No more than two lines of chemotherapy for advanced disease
- •Remaining side-effects from previous chemotherapy > grade 1 (except for alopecia)
- •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.
- •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.
- •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.
- •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)
- •Previously received trifluridine/tipiracil
- •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 C)
结局指标
主要结局
Percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with a taxane and capecitabine
Percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with a taxane and capecitabine
次要结局
- Progression free survival
- Response rate CR/PR at 16 weeks
- Adverse Events
- Quality of Life
研究者
BOOG Study Center
Scientific
BOOG Study Center B.V.
研究点 (1)
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