Aromatase Inhibitors (AI) Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Treatment in Postmenopausal Hormone Receptor-positive Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- effective rate
研究概览
简要总结
The investigators designed this study to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive breast cancer.
详细描述
The endocrine therapy has been used more and more in neoadjuvant treatment of hormone receptor-positive breast cancer. But it still a question if neoadjuvant endocrine therapy can be used combined with chemotherapy. There have been several small-sample studies concerning about this item and also got some results that support the suppose that endocrine therapy combined with chemotherapy could rise the effect of neoadjuvant treatment. This study is to investigate the effect of aromatase inhibitors (AI) plus chemotherapy versus chemotherapy as neoadjuvant treatment in postmenopausal hormone receptor-positive 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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •provision of informed consent
- •clinical stage IIA~IIIC
- •histologically proven HR+ invasive breast cancer
- •women defined as postmenopausal according to NCCN guideline
- •plan to accept the neoadjuvant (pre operational) chemotherapy treatment
排除标准
- •clinical evidence of metastatic disease
- •bilateral oophorectomy;
- •radiation of the ovaries
- •patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
- •patients who accepted anti-cancer treatment before
- •previous hormonal therapy as adjuvant treatment for non-cancer disease
- •patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop
- •previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
- •treatment with a non-approved or experimental drug during 1 month before entry into the study
- •history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin)
- •leukopenia and/or thrombocytopenia
- •history of ocular fundus diseases
- •history of thromboembolic diseases
- •history of osteoporotic fractures
研究组 & 干预措施
AI+Chemo
aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC*4-T*4) in patients with postmenopausal hormone receptor-positive breast cancer
干预措施: Letrozole (Aromatase Inhibitors) (Drug)
AI+Chemo
aromatase inhibitors (Letrozole 2.5mg po. QD for 5 years) starts at the beginning of neoadjuvant treatment combined with chemotherapy (AC*4-T*4) in patients with postmenopausal hormone receptor-positive breast cancer
干预措施: AC*4-T*4 (Drug)
Chemo
chemotherapy (AC*4-T*4) as neoadjuvant treatment without aromatase inhibitors in patients with postmenopausal hormone receptor-positive breast cancer
干预措施: AC*4-T*4 (Drug)
结局指标
主要结局
effective rate
时间窗: half year after randomized
CR+PR
次要结局
- pCR(half year after randomized)
- disease-free survival (DFS)(2 years after randomized)
- side effect rate(2 years after randomized)