Randomized Double-blind Study to Compare Two Neo-adjuvant Treatments: an Anti-aromatase vs SERM for Postmenopausal Women With ER+ Breast Adenocarcinoma: Effect on Intermediate Predictive Biological Response to Treatment.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the uptake of estrogen. Tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether letrozole or tamoxifen citrate is more effective when given before surgery in treating older women with breast cancer.
PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with tamoxifen citrate in treating older postmenopausal women undergoing surgery for breast cancer.
详细描述
OBJECTIVES:
Primary
- Investigate the changes in Ki67 and PCNA in postmenopausal women with estrogen receptor-positive (ER+) breast cancer after 4 months of treatment with letrozole vs tamoxifen citrate.
Secondary
- Compare the response after 4 months of therapy.
- Define the resistant forms of cancer in patients treated with these regimens.
- Define the molecular signature predictive of sensitivity or resistance to ER+ breast adenocarcinoma by gene and serum protein profiling.
- Search for serum protein profiles predictive of recurrence-free interval.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 120 Years（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 I
Patients receive oral letrozole once daily for 16 weeks.
干预措施: letrozole (Drug)
Arm II
Patients receive oral tamoxifen citrate once daily for 16 weeks.
干预措施: tamoxifen citrate (Drug)
结局指标
主要结局
Changes in Ki67 and PCNA after 4 months of treatment with letrozole vs tamoxifen citrate
时间窗: up to 24 months
次要结局
- Molecular signature predictive of sensitivity or resistance to estrogen receptor-positive breast adenocarcinoma(up to 24 months)
- Survival rate(up to 24 months)