NCT00485979已完成2 期
A Randomized, Open-label, Multi-center Study of Larotaxel at 90mg/m2 or Docetaxel Every 3 Weeks, Alone or in Combination With Trastuzumab According to Her2neu Status, Administered After a Combination of Anthracycline and Cyclophosphamide as Pre-operative Therapy in Patients With High Risk Localized Breast Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
研究概览
简要总结
The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).
The secondary objectives are:
- to assess in each treatment arm the clinical Response Rate (RR), the rate of breast conservation, the Progression-Free Survival (PFS), the Overall Survival (OS), the safety and tolerability profile, the pathological Complete Response rate (pCR) according to NSABP and Sataloff criteria,
- to rank docetaxel and larotaxel alone in Her2 -ve patients, or combined with trastuzumab in Her2 +ve patients, according to the pCR rate.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven invasive breast adenocarcinoma
- •Localized breast cancer: stage II and III
- •Tumors clinically palpable and ineligible for breast conservative surgery: unifocal tumor with diameter ≥ 3cm (clinical examination) or central unifocal tumor, or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate)
- •After 30 June 2008, known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)
排除标准
- •Bilateral and inflammatory breast cancer
- •Abnormal Left Ventricular Ejection Fraction
- •Distant metastases or locoregional relapse
- •Inadequate organ functions
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Arm A1
Experimental
Cohort 1: Her2-ve breast cancer
干预措施: larotaxel (XRP9881) (Drug)
Arm B1
Active Comparator
Cohort 1: Her2-ve breast cancer
干预措施: docetaxel (Drug)
Arm A2
Experimental
Cohort 2: Her2+ve breast cancer
干预措施: larotaxel (XRP9881) (Drug)
Arm A2
Experimental
Cohort 2: Her2+ve breast cancer
干预措施: trastuzumab (Drug)
Arm B2
Active Comparator
Cohort 2: Her2+ve breast cancer
干预措施: docetaxel (Drug)
Arm B2
Active Comparator
Cohort 2: Her2+ve breast cancer
干预措施: trastuzumab (Drug)
结局指标
主要结局
Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery.
时间窗: treatment period
次要结局
- Clinical Response Rate, Rate of breast conservation, Progression-Free Survival, Overall Survival, pathological response according to NSABP and Sataloff criteria for patients who underwent surgery(treatment period)
- Safety and tolerability profile(treatment period)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell CarcinomaResectable Esophageal Squamous Cell CarcinomaNCT04974047BeiGene70
进行中（未招募）
3 期
Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)NCT04379635BeiGene453
已完成
2 期
Study of Alimta® (Pemetrexed) Plus VELCADE® (Bortezomib) or Alimta Alone or VELCADE Alone in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior TherapyNon-Small Cell Lung CancerNCT00343720Millennium Pharmaceuticals, Inc.
Unknown
2 期
Taxotere®, Followed by Myocet® and Cyclophosphamide First Line Treatment in HER2 Neg Breast CancerBreast CancerNCT00721747Grupo Oncológico Gallego83
已完成
2 期
Explorative Phase II Study of Perioperative Treatment in Patients With Adenocarcinoma of the Gastroesophageal Junction or StomachAdenocarcinoma of the Gastroesophageal JunctionAdenocarcinoma of the StomachNCT01472029AIO-Studien-gGmbH53