Study to Assessment the Efficacy and Safety of Joint TAC and Exemestane as Neoadjuvant Chemotherapy in the Postmenopausal Women With Operable Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- therapeutic assessment
研究概览
简要总结
Select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.
详细描述
The investigators select the postmenopausal patients with breast cancer who is confirmed by core needle biopsy and at the clinical stage T2-4N0-2M0.Treat them with 4 cycles of TAC as neoadjuvant chemotherapy (Docetaxel was 75mg/m2, the EPI 60mg/m2 and the CTX 600mg/m2,21day/cycle).At the same time give daily oral exemestane 25mg for 12 weeks.Then assess the efficacy and safety of TAC and Exemestane.
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 invasive ductal carcinoma and estrogen receptor is positive
- •Tumor stage(TNM):T2-4bN0-3M0
- •Premenopausal woman
- •Not previously received treatment with bisphosphonate
- •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 or lactation 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
Exemestane
Exemestane for neoadjuvant chemotherapy
干预措施: Exemestane (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 years)
研究者
Zhang jin
Professor
Tianjin Medical University