The Effectiveness and Safety of Treating Operable Breast Cancer by the Adjuvant Therapy of Zoledronic Acid and Aromatase Inhibitors and/or Ovarian Function Inhibition
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- therapeutic assessment
研究概览
简要总结
Select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.
详细描述
The investigators select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.
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
- •Hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy
- •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
- •Surgery , radiotherapy and chemotherapy has finished
排除标准
- •Pregnant of 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
Zoledronic Acid and Aromatase Inhibitors
Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy
干预措施: Zoledronic Acid and Aromatase Inhibitors (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
Tianjin Medical University
Tianjin Medical University