A Phase II Study of Tesetaxel as First-line Therapy for Subjects With Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 81
- 试验地点
- 4
- 主要终点
- Response rate (revised RECIST)
研究概览
简要总结
The intravenously administered taxane, paclitaxel, is one of the most commonly employed agents for the treatment of both localized and advanced breast cancer.
Tesetaxel is an orally administered taxane that is in development as first- and second-line treatment for patients with advanced cancers. This study is being undertaken to determine the efficacy and safety of tesetaxel administered as first-line therapy to patients with metastatic breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years of age
- •Histologically or cytologically confirmed adenocarcinoma of the breast
- •Stage IV disease
- •HER2 status negative
- •Measurable disease (revised RECIST; Version 1.1)
- •Eastern Cooperative Oncology Group performance status 0 or 1
- •Life expectancy of at least 3 months
- •Chemotherapy naïve or 1 prior chemotherapy regimen in the adjuvant setting (Prior taxane-based adjuvant therapy allowed provided patient had a disease-free interval of at least 12 months after completing this adjuvant therapy)
- •Prior hormonal therapy, aromatase inhibitor therapy, and immunotherapy allowed
- •Prior radiotherapy in the adjuvant setting allowed provided that less than 25% of the bone marrow had been irradiated
- •Adequate bone marrow, hepatic, and renal function, as specified in the protocol
- •At least 4 weeks and recovery from effects of prior surgery, hormonal therapy, aromatase inhibitor therapy, immunotherapy, radiotherapy, or other therapy with an approved or investigational agent
- •Ability to swallow an oral solid-dosage form of medication
排除标准
- •Known metastasis to the central nervous system
- •History of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situ
- •Significant medical disease other than Stage IV breast cancer
- •Presence of neuropathy > Grade 1 (NCI CTC, Version 4.0)
- •History of hypersensitivity to a taxane
- •Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity
研究组 & 干预措施
Tesetaxel once every 3 weeks
Tesetaxel 27 mg/m2 orally once every 21 days for up to 12 months
干预措施: Tesetaxel once every 3 weeks (Drug)
Tesetaxel once weekly
Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks in a 28-day cycle for up to 12 months
干预措施: Tesetaxel once weekly (Drug)
结局指标
主要结局
Response rate (revised RECIST)
时间窗: 12 months from date of first dose of study medication for last patient enrolled
Proportion of patients with a confirmed complete or partial response
次要结局
- Disease control rate(12 months from date of first dose of study medication for last patient enrolled)
- Progression-free rate(6 months from date of first dose of study medication for last patient enrolled)
- Durable response rate(12 months from date of first dose of study medication for last patient enrolled)
- Duration of response(12 months from date of first dose of study medication for last patient enrolled)
- Time to progression(12 months from date of first dose of study medication for last patient enrolled)
- Adverse events(Up to 30 days after the last dose of study medication for a specific patient)