A Randomized Controlled Study to Evaluate the Efficacy and Safety of Endocrine Therapy Plus Chemotherapy Versus Chemotherapy Alone as the Neoadjuvant Therapy in the Treatment of ER-positive, HER2-negative Breast Cancer (IIa-IIIc)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- objective response rate (ORR)
研究概览
简要总结
This was an open-label, randomized controlled trial that aims to compare the efficacy and safety of the concurrent neoadjuvant chemotherapy with endocrine therapy and neoadjuvant chemotherapy alone in ER-positive, HER2-negative breast cancer.
详细描述
Data showed that concurrent neoadjuvant chemotherapy with endocrine therapy was a effective option for ER-positive, HER2-negative breast cancer patients. However this is still a controversial issue. The present study is an open-label randomized controlled clinical trial that aims to investigate the efficacy of concurrent NCT with endocrine therapy (AI with or without GnRH-a) in patients with ER-positive, HER2-negative breast carcinoma.
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
- •Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc.
- •Without previous chemotherapy or endocrine therapy.
- •ECOG scores of 0-2 points
- •With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma
- •Age: 18-70 years
- •Lateral breast cancer
- •Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions
排除标准
- •Pregnant women or nursing mothers
- •With distant metastasis
- •With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, in situ cervical cancer or other cured malignant tumor without the basis of recurrence for at least five years
- •With mental illness or other conditions affecting the patient compliance
- •With other serious diseases or medical conditions:
- •Congestive heart failure or unstable angina pectoris, myocardial infarction within 6 months before the enrollment, uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator
- •Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases may affect the understanding and sign of the informed consent for
- •Uncontrolled acute infection
- •Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study
- •With allergic constitution and any known or suspected drug allergy
- •Not suitable for the trial considered by the investigator
研究组 & 干预措施
neoadjuvant chemo-endocrine therapy
In the experimental arm, patients received concurrent chemotherapy (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles) with endocrine therapy (letrozole with or without leuprorelin) as a neoadjuvant treatment
干预措施: letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel (Drug)
neoadjuvant chemotherapy alone
In the control group, patients received neoadjuvant chemotherapy alone (fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles)
干预措施: fluorouracil, epirubicin, cyclophosphamide, docetaxel (Drug)
结局指标
主要结局
objective response rate (ORR)
时间窗: 4 years
the proportion of patients achieving clinical complete response and partial response in the breast based on magnetic resonance imaging
次要结局
- pathological response rate(4 years)
- Progression-free survival (DFS)(6 years)
- Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4)(4 years)
- Ki67 proliferation marker changes(4 years)
- pathologic complete response (pCR)(4 years)
研究者
Zhimin Shao
Director of Department of Surgical Oncology,Cancer Hospital & Institute
Fudan University