A Randomised Phase II Feasibility Study Investigating the Biological Effects of the Addition of Zoledronic Acid to Neoadjuvant Combination Chemotherapy on Invasive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5
研究概览
简要总结
There is clear preclinical in vitro and in vivo evidence of sequence dependent synergy between chemotherapy agents and zoledronic acid. The aim of the study is to investigate if the synergistic increase in tumour cell apoptosis observed in preclinical studies occurs in patients. The hypothesis for this study is that there may be anti-tumour benefits of the sequential application of chemotherapy agents followed by zoledronic acid in patients with invasive breast cancer.
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
- •Women with histological diagnosis of invasive breast cancer requiring neoadjuvant chemotherapy
- •T2 tumour or above
- •WHO Performance status of 0,1 or 2
- •Must consent to or have undergone a core biopsy for diagnosis of breast cancer AND consent to undergo an additional core biopsy prior to the second cycle of chemotherapy (Day 5 +/- Day 21)
- •Written informed consent
排除标准
- •Previous chemotherapy or radiotherapy to treated breast
- •Evidence of metastatic disease or recurrent breast cancer or previous malignancy (some exceptions)
- •Calculated creatinine clearance < 40mls/min
- •Prior treatment with bisphosphonates in last year or known contraindications to bisphosphonate therapy
- •Concurrent tamoxifen or aromatase inhibitor medication
- •Pregnant or lactating women
- •Cardiac dysfunction that precludes use of anthracycline chemotherapy
- •Unwilling to have extra interim biopsy
研究组 & 干预措施
A
Neoadjuvant chemotherapy alone
干预措施: 5-FU, Epirubicin, Cyclophosphamide, Docetaxel (Drug)
B
Neoadjuvant chemotherapy + zoledronic acid
干预措施: 5-FU, Epirubicin, Cyclophosphamide, Docetaxel, Zoledronic acid (Drug)
结局指标
主要结局
Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5
时间窗: Repeat biopsy on day 5 (+/- day 21)
次要结局
- Reduction in Ki67 immunostaining between preoperative core biopsy, repeat core biopsy on day 5, +/- day 21, and operative specimen(Day 5, +/- Day 21, surgical specimen)
- Changes in serum angiogenesis markers between pre-treatment and operative time points(Pre-treatment, Day 5, day 21, pre-surgery)
- Changes in bone biochemical markers between pre-treatment, treatment and operative timepoints(Pre-treatment, Day 5, day 21, pre-surgery)
- Detection of, and changes in, circulating tumour cells in peripheral blood taken pre-treatment, during treatment and following treatment(Pre-treatment, day 5, day 21, pre-surgery)