The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients: A Multicentric, Open-label, Non-randomized Concurrent Control, Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Pathological complete response rate
研究概览
简要总结
This is a multicentric, open-label,non-randomized concurrent control, 1:1 match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in breast cancer patients.
详细描述
OBJECTIVES: Determine the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in suitable breast cancer patients.
Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.
- Arm II: Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.
Patients in arms I and II will undergo physical examination, MRI, estimating of side effects every 4 cycles referring to RECIST (Response Evaluation Criteria In Solid Tumor) guideline. To adjust for potential bias, patients in DC-T arm were matched 1:1 to patients in the EC-T arm based on Her-2 and ER status. After finishing 8 cycles of neoadjuvant chemotherapy, every patient will receive mastectomy or breast-conserving surgery and then assess the pCR rate of primary lesion and axillary lymph nodes. Adjuvant radiotherapy and endocrine therapy will be taken if necessary. Every patient will be followed-up for five years to monitor survival condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Women aged : 18~70 years.
- •WHO (ECOG) performance status 0-
- •Patients who have read and understand the informed consent form and have given written informed consent.
- •Diagnosed as invasive breast cancer by core biopsy
- •Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy.
- •Patients had previously not received chemotherapy，radiotherapy or biotherapy.
- •Normal organ function，meeting the requirement of laboratory testing below:
- •WBC≥4.0×109/L,
- •NEU≥1.5×109/L,
- •PLT≥100×109/L,
- •HB ≥10g/dL,
- •Scr≤1.5× ULN,
- •AST ≤2.5×ULN,
- •ALT ≤2.5×ULN,
- •TDIL≤1.5×ULN.
- •Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline，（long diameter of primary lesion ≥1cm or minor diameter of lymph node ≥1.5cm）；
排除标准
- •Pregnant or lactating women were excluded.
- •History of receiving organ transplantation（including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation).
- •Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders.
- •Uncontrolled infection or severe peptic ulcer need treatment.
- •Severe hepatic disease（such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes.
- •Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin.
- •Significant abnormal EKG or cardiac disease with drastic symptoms like congestive heart failure or severe coronary disease or uncontrolled arrhythmia or myocardial infarction within 12 months or NYHA level III-IV or LVEF<55% .
- •Be allergic to test drugs.
研究组 & 干预措施
DC Follow T
Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.
干预措施: Docetaxel (Drug)
DC Follow T
Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.
干预措施: Pegylated liposomal doxorubicin (Drug)
DC Follow T
Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.
干预措施: Cyclophosphamide (Drug)
EC Follow T
Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.
干预措施: Cyclophosphamide (Drug)
EC Follow T
Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.
干预措施: Epirubicin (Drug)
EC Follow T
Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.
干预措施: Docetaxel (Drug)
结局指标
主要结局
Pathological complete response rate
时间窗: 5 years
The pathological complete response rate of primary lesion and axillary lymph nodes
次要结局
- Overall survival(5 years)
- Side effects(5 years)
研究者
Zhigang Zhang
Dr
Zhejiang University