A Randomized,Double-blind,Parallel-group,Multicentre,Phase II Study to Evaluate the Safety and Pharmacological Activity of the Combination of Vandetanib (100 or 300 MG/Daily or Placebo)With Fulvestrant (Loading Dose)in Postmenopausal Advanced BC Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Event Free Survival
研究概览
简要总结
The primary objective is to assess the event-free survival defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first..
详细描述
end-point Efficacy: event-free survival (EFS)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal women with locally advanced or metastatic breast cancer
- •Patients may have either measurable or non-measurable disease, as defined by RECIST criteria
- •One previous hormone therapy or one previous chemotherapy for advanced disease are allowed (patients who have stable but evident disease after chemotherapy are eligible)
- •estrogen receptor positive ER+ and/or progesterone receptor positive PR+ on primary or secondary tumour
排除标准
- •Hormone receptor negative tumours (ER and PR negative)
- •Presence of life-threatening metastatic visceral disease
- •Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within 3 months before entry, or presence of cardiac disease that in the opinion of
- •History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
研究组 & 干预措施
Vandetanib at the dose of 100 mg
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
干预措施: ZD6474 (Vandetanib at the dose of 100 mg) (Drug)
Vandetanib at the dose of 100 mg
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
干预措施: Fulvestrant (Drug)
Vandetanib at the dose of 100 mg
vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
干预措施: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg) (Drug)
Vandetanib at the dose of 300 mg
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
干预措施: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) (Drug)
Vandetanib at the dose of 300 mg
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
干预措施: Fulvestrant (Drug)
Vandetanib at the dose of 300 mg
vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
干预措施: ZD6474 (Vandetanib at the dose of 300 mg) (Drug)
Placebo to match vandetanib 100 mg and 300 mg
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
干预措施: Placebo to match ZD6474 (Vandetanib at the dose of 100 mg) (Drug)
Placebo to match vandetanib 100 mg and 300 mg
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
干预措施: Fulvestrant (Drug)
Placebo to match vandetanib 100 mg and 300 mg
placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
干预措施: Placebo to match ZD6474 (Vandetanib at the dose of 300 mg) (Drug)
结局指标
主要结局
Event Free Survival
时间窗: Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.
Success rate (patients without progression and still on treatment at 24 weeks
次要结局
- Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR)(Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.)
- Overall Survival(Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.)
- Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes(Continuous assessment of safety.)