Phase II Clinical Trial of Neoadjuvant Treatment With Zolendronic Acid Plus Anthracycline and Taxane in Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Evaluate the residual cancer burden (RCB)
研究概览
简要总结
The purpose of this study is to evaluate the association of zoledronic acid with standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER 2 positive.
详细描述
This trial combines zolendronic acid with anthracycline followed taxane plus trastuzumab for neoadjuvant treatment of HER 2 positive stage II/III breast cancer.
Zoledronic acid (ZOL) has activity of anti-bone resorption and shows diverse anti-tumor effects in vitro. Some chemical and biological characteristics of ZOL indicate potential for inhibition of tumor growth in pre clinical studies
The primary objective of the study is to evaluate the residual cancer burden (RCB) with the addition of zolendronic acid to standard neoadjuvant therapy. RCB is calculated as a continuous index combining pathologic measurements of primary tumor (size and cellularity) and nodal metastases (number and size). RCB index is a significant predictor of distant relapse-free survival, and can be used to define categories of near-complete response and chemotherapy resistance after neoadjuvant chemotherapy compared with currently used risk factors. Additionally, the study will collect tissue biopsies and blood before and after treatment in order to correlate clinical outcomes with gene expression and radiologic data to predictive response.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage IIA to IIIB HER-2 positive breast cancer
- •ECOG performance ≤ 2
- •Adequate hematologic function with:
- •Absolute neutrophil count (ANC)> 1500/mm³
- •Platelets ≥ 100.000/mm³
- •hemoglobin ≥ 9g/dL
- •Adequate hepatic and renal function with:
- •Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤ 2.5 x the institutional upper limit of normal (ULN)
- •Alkaline phosphatase )≤ 2.5 x the institutional upper limit of normal (ULN)
- •Serum creatinine ≤ 1.5 x the institutional upper limit of normal (ULN) or calculated creatinine clearance > 50 mL/min
- •Adequate cardiac function
- •Left ventricular ejection fraction (LVEF)with institutional normal range
- •Knowledge of the investigational nature of the study and ability to provide consent for study participation
排除标准
- •Previous diagnostic of breast or other cancer
- •Metastatic breast cancer
- •Bilateral, synchronous breast cancer
- •Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that woud make the patient inappropriate for this study
- •Neuropathy grade > 2 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
研究组 & 干预措施
Zometa neoadjuvant HER2 breast cancer
Zo-Nantax arm - Neoadjuvant chemotherapy with association of zoledronic acid and standard treatment with anthracycline followed taxane plus trastuzumab in locally advanced breast cancer HER2 positive HR positive/negative.
Drug:Cyclophosphamide Drug:Adriamycin Drug:Docetaxel Drug:Trastuzumab Drug:Zolendronic acid
干预措施: Zo-Nantax (Drug)
结局指标
主要结局
Evaluate the residual cancer burden (RCB)
时间窗: 6 months
Use MD Anderson calculator to quantify the minimal residual disease
次要结局
- Assessing the tolerance to standard neoadjuvant treatment plus zolendronic acid,according to the common toxicity criteria Terminology Criteria for Adverse Events version 3.0.(6 months)
- Assessment of the difference in gene expression according to treatment response(6 months)
- Prediction of pathological response by MRI calculated from the sequence of apparent diffusion coefficient (ADC)(4 months)
研究者
Susanne Crocamo
Clinical Oncologist
Instituto Nacional de Cancer, Brazil