NCT00237198已完成2 期
Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Response Rate during treatment
研究概览
简要总结
- Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy in postmenopausal patients with advanced breast cancer who received previous anti-estrogen treatment
- To investigate changes in blood drug concentrations and blood hormone kinetics.
- To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of letrozole
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically documented breast cancer
- •Patients with progressive breast cancer (advanced breast cancer, locoregional recurrence not operative, or metastatic breast cancer)
- •Patients with hormone receptor (ER and/or PgR) positive or both unknown.
- •Postmenopausal patients between ages 20 and 79 years, inclusive
- •Patients with a history of adjuvant therapy or advanced breast cancer treated with anti-estrogens
- •Patients with documented measurable or evaluable lesions.
- •Patients with sufficient organ function to evaluate the safety
- •Patients whose performance status (PS) is 0～2
排除标准
- •Patients with diffuse lymphangitis carcinomatosa of the lung or CNS involvement, liver metastasis occupying more than one third of the liver, or inflammatory breast cancer
- •Patients with other concurrent or previous malignant disease (excluding contralateral breast cancer, in situ carcinoma of cervix uteri, and adequately treated basal or squamous cell carcinoma of the skin)
- •Patients in whom one of the following is the sole manifestation of disease: hilar enlargement, pleural effusion and ascites
- •Patients with only blastic bone metastases or a mixed blastic and lytic bone metastases at the same site and no other measurable or evaluable lesions
- •Patients with serious current disease such as uncontrolled cardiac diseases and/or uncontrolled diabetes mellitus by any medications (including a historical serious cardiac disease)
- •Patients with adrenal insufficiency (treated or untreated) or Cushing's syndrome
- •Patients with any of the following previous treatments
- •Chemotherapy for metastatic and/or locoregional recurrent disease
- •Previous adjuvant endocrine therapy other than ovariectomy, anti-estrogen treatment, LH-RH analogues or radiation castration
- •Previous first-line endocrine therapy (e.g., aromatase inhibitors and gastagens) for the treatment of metastatic and/or locoregional recurrent breast cancer other than anti-estrogen or LH-RH analogues treatment
- •Patients who have not recovered from toxicity caused by previous therapy
- •For patients on investigational drugs, adequate wash-out periods of at least 7 days in the case of topical investigational drugs and at least 30 days in the case of systemic
- •Previous bisphosphonate therapy started within 6 months without any other measurable or evaluable lesions
- •Patients who have not stopped treatment with other anti-estrogen or anti-cancer drugs (other than bisphosphonates) before starting the trial medication
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Letrozole
Experimental
干预措施: Letrozole (Drug)
结局指标
主要结局
Response Rate during treatment
时间窗: Until disease progression or appearance of unacceptable toxicity whichever comes first
Safety during treatment
时间窗: Until disease progression or appearance of unacceptable toxicity whichever comes first
次要结局
- Clinical Benefit Rate during treatment(Until disease progression or appearance of unacceptable toxicity whichever comes first)
- Duration of response(from the first date of response confirmed and the last date of response confirmed)
- Time to progression(from the first date of response confirmed and the last date of response confirmed)
- Time to treatment failure(from the date of study initiation and the date of disease progression confirmed or discontinuation other than disease progression)
- Plasma drug concentration from baseline, every 4 weeks until 28 weeks, at 40 weeks and at 52 weeks(Baseline, 52 weeks)
- Plasma estrogens level(baseline, 52 weeks)
研究者
研究点 (1)
Loading locations...
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