A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 116
- 试验地点
- 6
- 主要终点
- Clinical tumor response as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.
PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To compare the clinical response rates (complete and partial responses) at 6 months in postmenopausal women with operable stage II or III breast cancer treated with neoadjuvant anastrozole vs fulvestrant.
Secondary
- To compare the breast surgery conservation rate in patients treated with these drugs.
- To correlate imaging findings by mammography, ultrasonography, and MRI with histological and clinical response in these patients and with sensitivity profile to these drugs.
- To compare histological response in patients treated with these drugs.
- To define criteria appropriate for neoadjuvant hormonal therapy.
- To correlate baseline molecular characteristics and modifications during treatment with response in these patients.
- To compare the tolerability of these drugs in these patients.
- To compare the serum proteomic profile of patients treated with these drugs.
- To correlate 3-year event-free and overall survival rates with clinical and histological response in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Anastrozole
干预措施: anastrozole (Drug)
Arm B
Fulvestrant
干预措施: fulvestrant (Drug)
结局指标
主要结局
Clinical tumor response as assessed by RECIST criteria
时间窗: 6 months
次要结局
- Relapse-free survival rate(3 years)
- Histological tumor response as assessed by the Sataloff scale(Post surgery)
- Overall survival rate(3 years)
- Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI(at baseline, after the first month of treatment, and then before surgery)
- Event-free survival rate(3 years)
- Breast surgery conservation rate(Post surgery)
- Biological prognosis and predictive response factors(3 years)
- Toxicity as assessed by NCI CTCAE v3.0(During neoadjuvant treatment)