EUCTR2012-003505-10-IT进行中（未招募）1 期
Phase II study of Eribulin in combination with Gemcitabine for the First-line Treatment of Patients with Locally Recurrent or Metastatic Triple Negative Breast Cancer. Protocol ERIGE. - ERIGE
GRUPPO ONCOLOGICO ITALIANO DI RICERCA0 个研究点目标入组 83 人开始时间: 2012年10月25日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 83
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patients must have locally recurrent or metastatic breast cancer. Patients must have estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), human epidermal growth factor receptor 2-negative (Her2-) (0, 1+) or, e.g. in HER2 2+ cases, fluorescent in situ hybridization (FISH) < ratio of 1.8. Cancer recurrent after previous neoadjuvant and/or adjuvant chemotherapy including an anthracycline and a taxane (unless one or both were clinically contraindicated). Measurable disease. Prior diagnosis of cancer is allowed as long as patient is free of disease and has been off treatment for the prior malignancy for a minimal interval of 3 years. Patients must have a life expectancy of > 12 weeks. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 50%). Adequate bone marrow reserve, liver and renal function. All patients must have given signed, informed consent prior to registration on study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •Prior gemcitabine or eribulin. Any prior chemotherapy for metastatic disease. Patients with brain metastases
研究者
相似试验
招募中
2 期
Phase II study of the combination of Eribulin and Trastuzumab Evaluating Efficacy and Safety in Patients with advanced/recurrent HER2-positive breast cancer.Advanced/recurrent HER2-positive breast cancerJPRN-UMIN000011020Sairtama Breast Cancer Clinical Study Group (SBCCSG)na35
进行中（未招募）
1 期
A Phase II study of a Combination of Eribulin and capecitabiNe in second line Treatment after the failure of gemcitabine/abraxane first line in advanced pancreatic canceradvanced pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864EUCTR2017-003621-15-ITAZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA25
已完成
2 期
A phase II study of eribulin in combination with trastuzumab and pertuzumab as First-Line therapy for metastatic HER2-positive breast cancerFirst-Line therapy for metastatic HER2-positive breast cancer.JPRN-UMIN000021585Sairtama Breast Cancer Clinical Study Group (SBCCSG)16
已完成
2 期
A phase 2 study of eribulin in combination with pertuzumab and trastuzumab for advanced or recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancerJPRN-UMIN000014107SONG (South Osaka Network Group for Breast Cancer)43
已完成
不适用
A Phase II Study of Eribulin Evaluating Efficacy and Safety as first or secondary line chemotherapy for advanced or metastatic breast cancer without HER2 overexpressingAdvanced or metastatic breast cancerJPRN-UMIN000009568General and Gastroenterological Surgery, Osaka Medical College35