Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Non-metastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) Determined by Clinical Palpation
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given the lack of clinical data on fulvestrant in patients with large operable or locally advanced hormone-receptor-positive breast cancer, and the potential to identify differences in the mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre randomised phase II clinical trial of anastrozole and fulvestrant.
PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment.
详细描述
OBJECTIVES:
Primary
- Evaluate clinical tumor response at 6 months in patients with hormone-sensitive non-metastatic breast cancer treated with neoadjuvant anastrozole and fulvestrant.
Secondary
- Evaluate tumor regression by mammography and ultrasound in these patients.
- Evaluate the rate of breast conservation at 6 months of treatment in these patients.
- Evaluate the tolerability of these regimens.
- Estimate the relapse-free survival at 5 years.
- Identify molecular signatures predictive of response in these patients.
- Identify genes implicated in response in these patients.
- Identify changes in mRNA splicing of genes involved in breast tumorigenesis.
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
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A (ANA)
Patients receive oral anastrozole as 1 mg film-coated tablets, once daily for 6 months.
干预措施: anastrozole (Drug)
Arm B (FULV)
Patients receive fulvestrant intramuscularly ( 250 mg/5 ml solution) on days 1, 14, and 28 and then once a month thereafter until 6 months.
干预措施: fulvestrant (Drug)
结局指标
主要结局
Objective Response Rate (ORR) Determined by Clinical Palpation
时间窗: 6 months
Objective response rate is defined as the rate of participants with partial or complete responses according to RECIST V1.0. Complete response is defined as the disappearance of all target lesions and partial response is defined as at least a 30% decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD (RECIST V1.0.).
次要结局
- Objective Response Rate (ORR) Determined by Mammography(6 months)
- Percentage of Participants With 5-year Relapse-Free Survival(5 years)
- Objective Response Rate (ORR) Determined by Ultrasound(6 months)
- Rate of Breast-conserving Surgery(6 months)