Zoledronic Acid as Adjuvant Treatment of Triple-negative Breast Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 430
- 主要终点
- disease free survival
研究概览
简要总结
Triple-negative breast cancer is a special type of breast cancer with poor prgnosis and limited choices. Chemotherapy is the only choice of adjuvant systemic treatment options. Previous study suggested that zoledronic acid might have anti-tumor effect by eliminating the number of DTCs(Disseminated Tumor Cell )and had been proved to be effective as adjvant therapy in postmenopausal women whose breast cancer was Homonal receptor positive and who were receiving aromatase inhibitors. So it might be able to improve the survival of triple negative breast cancer patients.
详细描述
Triple negative breast cancer patients with high risk factor will be randomized to receive either zoledronic acid or observation after the completion of standard chemotherapy/radiotherapy. Recurrence status will be followed and Disease free survival will be compared. Overall survival is the secondary endpoint.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- ••Adult women (≥ 18 years of age) with early stage breast cancer(stage II-III).
- •Histological confirmation of estrogen and/or progesterone-receptor negative (ER-), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer.
- •ER/PR negative: nuclear reaction< 1%, HER2 negative: HER2; IHC 0,1+ or FISH/CISH (-) in case of IHC 2+
- •axillary lymph node positive with other high risk factors: LVI, T>5CM, Grade III
- •Patients finish standard chemotherapy and/or radiotherapy
- •ECOG performance status of 0,1
- •Adequate bone marrow, hepatic, and renal function
- •Adequate bone marrow and coagulation function as shown by:
- •Absolute neutrophil count (ANC) ≥ 1.5 109/L;Platelets>100 x109/L;Hemoglobin (Hgb) > 9.0g/dLINR < 2
- •Adequate liver function as shown by:
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5x ULN
- •Total serum bilirubin < 1.5 x ULN
- •Adequate renal function as shown by:
- •Serum creatinine< 1.5 x ULN
- •Fasting serum cholesterol <300 mg/dL or 7.75 mmol/L and fasting triglycerides <2.5 x ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved.
- •Written informed consent
排除标准
- ••Another malignancy within 5 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.
- •Any severe and/or uncontrolled medical conditions, eg. currently active infection
- •Pregnant or lactating
- •Patients unwilling to or unable to comply with the protocol
研究组 & 干预措施
A
zoledronic acid received
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
disease free survival
时间窗: 3 years after last patient was enrolled
the time from randomization to the time of disease progression or relapse or death
次要结局
- overall survival(5 years after last patient was enrolled)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(up to 28 days after last medication)
研究者
Ying Fan
Associate professor
Chinese Academy of Medical Sciences