A Phase II, Randomized, Double-Blinded Efficacy and Safety Study of Three Doses of TAS-108 Administered Orally in Postmenopausal Patients With Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Cancer Following Standard First-Line Endocrine Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- To determine the time to progression of TAS-108 administered on this schedule
研究概览
简要总结
This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer.
详细描述
The objective of this study is to investigate the efficacy and safety of TAS-108 administered in postmenopausal patients with locally advanced or locally recurrent inoperable or progressive metastatic breast carcinoma who have previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal females
- •Histologically or cytologically confirmed diagnosis of breast carcinoma
- •Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
- •Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
- •Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
- •Performance status of greater than or equal to 2 on the Zubrod scale
- •Predicted life expectancy of greater than or equal to 12 weeks
- •Must give written informed consent
- •Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •Absolute granulocyte count of greater than 1,500/meqL, platelet count greater than 75,000/meqL, and a hemoglobin of greater than 10 g/dL
- •Adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
- •Transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
- •The patient has recovered from all previous anti-cancer treatment related to toxicities to at least Grade
- •All previous investigational drugs must be stopped at least four weeks before commencement of treatment with TAS-108.
排除标准
- 未提供
研究组 & 干预措施
TAS-108 40 mg
干预措施: TAS-108 (Drug)
TAS-108 80 mg
干预措施: TAS-108 (Drug)
TAS-108 120 mg
干预措施: TAS-108 (Drug)
结局指标
主要结局
To determine the time to progression of TAS-108 administered on this schedule
时间窗: Up to 4 years and 3 months
To evaluate the safety of TAS-108 administered on this schedule
时间窗: Up to 4 years and 3 months
Treatment-emergent adverse events, serious adverse events, bone mineral density
To investigate the comparative concentrations of TAS-108 and its metabolites in tumor tissue and blood at steady-state
时间窗: Up to 4 years and 3 months
次要结局
未报告次要终点