EUCTR2013-000829-31-NL进行中（未招募）1 期
A LOCAL, OPEN LABEL, MULTICENTRE, PHASE IIIB STUDY, INVESTIGATING SUBCUTANEOUS TRASTUZUMAB ADMINISTERED AT HOME WITH SINGLE INJECTION DEVICE IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER - HOMERUS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
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
入选标准
- •1. Female and male patients aged = 18 years
- •2. Eastern Cooperative Oncology Group (ECOG) performance status 0–1
- •3. Hormonal therapy will be allowed as per institutional guidelines
- •4. Prior use of anti-HER2 therapy in combination with chemotherapy will be allowed
- •5. Left ventricular ejection fraction (LVEF) of = 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrolment.Except in case patient received anthracycline treatment previously then documented results within an acceptable limit from a cardiac assessment within 14 days prior to enrolment.
- •6. HER2-positive disease immunohistochemistry (IHC)3+ ISH positive or MLPA positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
- •7. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
- •8. No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- •9. Use of concurrent curative radiotherapy will be permitted
- •10. Completion of surgery and chemotherapy (if applicable) for eBC
- •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 113
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. History of other malignancy which could affect compliance with the protocol or interpretation of results.
- •2. Patients with severe dyspnea at rest or requiring supplementary oxygen therapy
- •3. Patients with other concurrent serious diseases that may interfere with planned treatment
- •4. Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
- •5. Pregnant or lactating women.
- •6. Women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, unless surgically sterile), and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment. In this study, menopause is defined as a minimum of 12 consecutive months of amenorrhea during which time no other biological or physiological cause had been identified as a potential cause of this state. Examples of adequate contraceptive measures are intrauterine device, barrier method (condoms, diaphragm) also in conjunction with spermicidal jelly, or total abstinence. Oral, injectable, or implant hormonal contraceptives are not acceptable. Use of hormonal IUDs is up to discretion of the physician.
- •7. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
- •8. Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin® including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions
- •9. Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- •10. Impaired hepatic function
- •11. Inadequate renal function
研究者
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