A Study to Assess the Efficacy and Safety With Albumin-bound Paclitaxel (Abraxane) in the TAC as Neoadjuvant Chemotherapy in the Treatment of Operable Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- therapeutic assessment
研究概览
简要总结
Select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.
详细描述
The investigators select 60 cases of women with breast cancer at clinical stage of T1-4N0-2M0. Then treat them with 4 cycles of TAC (Abraxane 260mg/m2,EPI 60 mg/m2 ,CTX 500 mg/m2, 21day/cycle) as neoadjuvant chemotherapy. Finally the investigators assess the efficacy and safety of Albumin-bound Paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Karnofsky ≥ 70
- •Provision of informed consent
- •Pathological confirmation of breast cancer
- •Tumor stage (TNM):T2-4bN0-3M0
- •Measurable disease as per RECIST criteria
- •Not previously treated with radiotherapy, chemotherapy or biological therapy.
- •Laboratory criteria:
- •PLT ≥ 100*109/L
- •WBC ≥ 4000/mm3
- •HGB ≥ 10g/dl
- •GOT,GPT,ALP ≤ 2*ULN
- •TBIL,DBIL,CCr ≤ 1.5*ULN
排除标准
- •Pregnant woman
- •History of organ transplantation
- •With mental disease
- •With severe infection or active gastrointestinal ulcers
- •With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes
- •Disease-free period of other malignant tumor is less than 5 years (except cured basal cell skin cancer and cervical carcinoma in situ)
- •With heart disease
- •Experimental drug allergy
研究组 & 干预措施
Abraxane
Abraxane for neoadjuvant chemotherapy
干预措施: Abraxane (Drug)
结局指标
主要结局
therapeutic assessment
时间窗: 6 months
therapeutic assessment
次要结局
- Adverse reactions and disease-free survival(2 year)
研究者
Zhang jin
Professor
Tianjin Medical University