NCT01622361Unknown3 期
A Phase III, Open-Label, Prospective, Randomized, Multicenter, Neo-adjuvant Study of Chemotherapy Versus Endocrine Therapy in Premenopausal Patient With Hormone Responsive, HER2 Negative, Lymph Node Positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this study is to compare neo-adjuvant therapy of cytotoxic chemotherapy versus GnRHa with tamoxifen , of response rate(RR) in patients of hormone responsive and HER2 negative, lymph node positive, primary breast cancer in premenopausal women.
详细描述
- Primary objective
: Response Rate-MRI and/or Caliper 2. Secondary objectives
- Pathologic complete response
- Rate of conservation surgery
- Ki-67 changes and its relationship to treatment response
- Length of time to maximum response within the treatment period
- Tolerability of two treatments
- Disease-free survival(DFS)
- Overall survival
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven primary invasive breast cancer which is thought to be suitable for neo-adjuvant treatment
- •Pathologically proven lymph node positive tumor(FNAB or Core biopsy)
- •Tumor must be ER positive(eligible patients include Allred score 5 and more, Modified Allred 4 and more) and HER-2 negative(IHC score is 0-1+; If IHC score is 2+, the result of FISH or SISH is negative)
- •Premenopausal women
- •Premenopausal status as defined by :
- •Last menses within 6 month of randomization or
- •For patients who have had a unilateral oophorectomy, E2 ≥ 20PG/mL and FSH < 30mIU/Ml within 4 weeks of randomization
- •over 20 years old
- •Pre-treatment haematology and biochemistry values within acceptable limits :
- •ANC ≥ 1.5 × 109/l
- •Hb > 9g/dl
- •Platelets ≥ 100 × 109/l
- •AST/ALT ≤ 1.5 × ULN(Upper Limit of Normal)
- •ALP ≤ 1.5 × ULN
- •Serum bilirubin ≤ 1.5 × ULN
- •Serum creatinine ≤ 1.5 × ULN
- •ECOG PS of 0 or 1
- •No concomitant medical, psychiatric or geographic problems that might prevent completion of treatment or follow-up
- •Before any study-specific procedures, the appropriate written informed consent must be obtained
排除标准
- •Inflammatory breast cancer
- •Inoperable disease that is judged very unlikely to be rendered operable by neo-adjuvant treatment
- •Known severe hypersensitivity to GnRHa treatment
- •Bilateral invasive breast cancer
- •Other serious illness or medical condition:
- •congestive heart failure or unstable angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or high-risk uncontrolled arrhythmias
- •history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
- •active uncontrolled infection
- •HRT within 4 weeks of starting treatment
- •Definite contra-indications for the use of corticosteroids.
- •Last 10 years with a history of other malignant tumor (except in the case of basal cell carcinoma or cervical carcinoma in situ, and where treatment consisted solely of resection)
- •Systemic metastatic (Tests for the diagnosis of systemic metastatic comply with the guideline in each institution)
- •Pregnant or breastfeeding women
- •Chronic oral treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose (≤ 20 mg methylprednisolone or equivalent).
研究组 & 干预措施
Chemotherapy Group
Active Comparator
Chemotherapy Adriamycin+Cyclophosphamide>Docetaxel
干预措施: Adriamycin+Cyclophosphamide>Docetaxel (Drug)
Endocrine therapy group
Experimental
Endocrine therapy(GnRHa with Tamoxifen) group
干预措施: GnRHa with Tamoxifen (Drug)
结局指标
主要结局
Response Rate
时间窗: 6 months
次要结局
- Pathologic complete response(6 months)
研究者
Sei-Hyun Ahn
M.D., Ph.D.
Asan Medical Center
研究点 (1)
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