EUCTR2017-004652-35-IT进行中（未招募）1 期
Second line ERIbulin followed by CApecitabine or the reverse sequence in HER2-negative Metastatic Breast Cancer (MBC) patients: a randomized phase II study – ERICA trial - Second line ERIbulin followed by CApecitabine or the reverse sequence in HER2-negative Metastatic Br
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •1.Written informed consent (both for clinical and blood biomarker study);
- •2.Histological diagnosis of HER2 negative MBC;
- •3.Females >= 18;
- •4.Measurable disease (according RECIST criteria version 1.1)
- •5.Prior Anthracyclines and Taxanes
- •6. 1 prior cytotoxic regimen for advanced or MBC (not including adjuvant or neo-adjuvant therapy). Patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 6 months of (neo-) adjuvant cytotoxic therapy that included anathracyclines and taxanes;
- •7.Prior hormonotherapy and Cyclines inhibitors are allowed, so as indicated in the international guidelines for the management of hormone positive breast cancer (ER and/or PR positive);
- •8.ECOG Performance Status <= 2
- •9.Absence of angina or heart failure or infarction within 12 months from inclusion;
- •10.Adequate bone marrow and organ function as follows (haemoglobin >= 9.0 g/dl; absolute neutrophil count >= 1.5x103/mm3; plateled count >= 100x103/mm3; bilirubin levels <= 1.5 times Upper Limits of Normal - biliary stenting is allowed to resolve obstruction – Serum Transaminase level <= 2.5 times ULN; serum creatinine <= 1.5 times ULN
- •11.Life expectancy of at least 12 weeks
- •12.If women of childbearing potential age: effective contraceptive measures must be used during the study treatment period and up to 3 months after the last dose of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1.Unability to give informed consent;
- •2.Absence of measurable disease;
- •3.Concurrent active malignancies (except of in situ carcinoma of the cervix and inactive non-melanoma skin cancer);
- •4.Current active infection;
- •5.Serious pre-existing medical conditions or serious concomitant diseases;
- •6.Systemic disorders that would compromise the safety of the patient or her ability to complete the study, at the discretion of the investigator (for example, unstable angina pectoris, or a clinically significant history of cardiac disease or uncontrolled diabetes mellitus);
- •7.Known immunodeficiency virus infection;
- •8.Pregnant or breastfeeding women;
- •9.Unable to undergo medical test for geographical, social or psychological reason
- •10.Active or symptomatic brain metastases.
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