NCT00234403已完成2 期
A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
研究概览
简要总结
The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically confirmed advanced or metastatic breast cancer
- •postmenopausal females with amenorrhoea > 12 months and an intact uterus
- •FSH levels within postmenopausal range or have undergone a bilateral oophorectomy
- •ER &/or PR positive
- •previous adjuvant hormone therapy > 12 months prior to enrolment
- •previous adjuvant chemotherapy > 6 months prior to enrolment
- •measurable disease according to RECIST and/or non measurable bone disease
- •life expectancy of at least 12 weeks
- •World Health Organisation (WHO) performance status (PS) of 0 to 1.
排除标准
- •life-threatening metastatic visceral disease
- •evidence of clinically active interstitial lung disease
- •ER and PR negative
- •treatment with LHRH analogues < 3 months prior to enrolment
- •patients who have restarted menses or do not have FSH levels within the postmenopausal range
- •treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months
- •Treatment with hormonotherapy and/or chemotherapy for advanced disease
- •extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. >30% of bone marrow, e.g. whole of pelvis or half of spine)
- •currently receiving oestrogen replacement therapy
- •treatment with a non-approved or experimental drug within 4 weeks before enrolment
- •absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy
- •any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known
- •severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.
结局指标
主要结局
To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
次要结局
- To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
- To estimate the disease control rate at trial closure.
- To estimate overall survival.
- To evaluate the safety & tolerability of the combination gefitinib and fulvestrant
研究者
研究点 (7)
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