NCT00256698已完成3 期
FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP)
研究概览
简要总结
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis
排除标准
- •Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
- •Premenopausal women
研究组 & 干预措施
1
Active Comparator
Anastrozole
干预措施: Anastrozole (Drug)
2
Experimental
Anastrozole + Fulvestrant
干预措施: Fulvestrant (Drug)
2
Experimental
Anastrozole + Fulvestrant
干预措施: Anastrozole (Drug)
结局指标
主要结局
Time to Progression (TTP)
时间窗: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.
次要结局
- Percentage of Evaluable Participants With Objective Response Rate (ORR)(RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009)
- Percentage of Clinical Benefit Rate (CBR) Responders(RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009)
- Duration of Response (DoR)(RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009)
- Duration of Clinical Benefit (DoCB)(RECIST tumour assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009)
- Time to Treatment Failure (TTF)(From randomisation until data cut-off on 30th April 2009)
- Overall Survival (OS)(All deaths occurring between randomisation and data cut-off on 30th April 2009 are included.)
研究者
研究点 (1)
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