EUCTR2013-001023-39-AT进行中（未招募）不适用
ISAH: AN OPEN-LABEL, RANDOMISED PHASE II STUDY ASSESSING QUALITY OF LIFE ASSOCIATED WITH SUBCUTANEOUS TRASTUZUMAB INJECTED INTO THE THIGH OR UPPER ARM IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER - LISAH
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Female and male patients aged = 18 years
- •2.Signed informed consent prior to any study specific procedure
- •3.Able and willing to comply with protocol
- •4.Eastern Cooperative Oncology Group (ECOG) performance status 0–1
- •5.Hormonal therapy will be allowed as per institutional guidelines
- •6.Patients must be trastuzumab naïve
- •7.Left ventricular ejection fraction (LVEF) of = 55% 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
- •8.HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
- •9.Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
- •10.No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
- •11.Use of concurrent curative radiotherapy will be permitted
- •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 47
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1.History of other malignancy which could affect compliance with the protocol or interpretation of results. Patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible
- •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, including severe pulmonary conditions/illness
- •4.Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
- •5.Pregnant or lactating women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days prior to the first dose of study drug
- •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
- •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 a history of severe allergic or immunological reactions, e.g. difficult to control asthma
- •9.Patients assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol
- •10.Inadequate bone marrow function (as indicated by any of the following):
- •a)Absolute neutrophil count (ANC) < 1,500 / mm3 (< 1.5 × 109/L)
- •b)Platelets < 100,000 / mm3 (< 100 × 109/L)
- •c)Hemoglobin < 10 g/dL
- •11.Impaired hepatic function (as indicated by any of the following):
- •a)Serum total bilirubin > 1.5 × upper limit of normal (ULN)
- •b)Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) > 2.5 × ULN
- •c)Alkaline phosphatase (ALP) > 2.5 × ULN
- •12. Inadequate renal function, as indicated by serum creatinine > 1.5 × ULN
研究者
相似试验
进行中（未招募）
1 期
Safety, tolerability, and efficacy of a combination of MTL-CEBPA and sorafenib in patients with advanced liver cancer with a viral background.Advanced hepatocellular cancer (HCC) in association with hepatitis B and/or hepatitis CMedDRA version: 20.0Level: PTClassification code 10073071Term: Hepatocellular carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10036706Term: Primary liver cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-005431-23-NLMiNA Alpha Limited150
进行中（未招募）
1 期
Safety, tolerability, and efficacy of a combination of MTL-CEBPA and sorafenib in patients with advanced liver cancer with a viral background.EUCTR2021-005431-23-SEMiNA Alpha Limited150
进行中（未招募）
不适用
An open label, single institution, phase II study of the mTOR inhibitor temsirolimus in unresectable and/or metastatic renal cell carcinoma (RCC) in patients previously treated with both cytokines and one ore more tyrosine kinase inhibitor, The TeRCC study - NDrenal cell carcinomaEUCTR2007-007045-12-ITOSPEDALE POLICLINICO S. MATTEO
已完成
2 期
To assess the safety and effectiveness of DPOR/JR2007 Tablets in Osteoarthritis of the Knee.CTRI/2017/07/009054Deltas Pharma45
已完成
2 期
To evaluate the safety and efficacy of Arnophyte Cream in subjects with HerpesCTRI/2018/01/011171Piramal Enterprises Limited40