Randomized Trial of Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With Estrogen Receptor-Positive HER2 Negative Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- ultrasound response rate
研究概览
简要总结
This study proposes to prove that the efficacy of adjuvant endocrine therapy for the premenopausal HR positive breast cancer patients is non-inferiority to adjuvant chemotherapy assessed by ultrasound response rate.
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
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •35 years old <age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer
- •Stage: T2N0M0(cT>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast)
- •Histologically confirmed HR+ (ER or PR positive, and >50% cell in IHC) HER2 negative breast cancer by pathological evaluation
- •No other previous treatment for primary breast cancer
- •Without other tumor or unstable complication or uncontrolled infection
- •No contradiction for the third generation AIs, LHRHa, chemotherapy
- •Attend the study voluntarily, sign the informed consent.
排除标准
- •Metastasis disease by pathological or radiological diagnosis
- •the history of other tumor
- •contradiction for the third generation AIs, LHRHa, chemotherapy
- •Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy
- •Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive
- •other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem
- •have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study
研究组 & 干预措施
Endocrine therapy;
Interventions：Goserelin+TAM+AI：Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks.
干预措施: Goserelin+TAM+AI (Drug)
Chemotherapy
Interventions：Epirubicin+CTX+5-Fu：Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles.
干预措施: Epirubicin+CTX+5-Fu (Drug)
结局指标
主要结局
ultrasound response rate
时间窗: within 2 weeks before surgery
次要结局
- pathological response rate(Miller & Payne standard)(with 2 weeks after surgery)
研究者
Tao OUYANG
Chairman of Breast Center of Peking University Cancer Hospital
Peking University