EUCTR2005-000558-60-HU进行中（未招募）不适用
A Phase II trial evaluating the immunological and clinical efficacy and safety of HER-2 Protein AutoVac(TM) and Stimulon® Adjuvant QS-21 monotherapy in patients with metastatic breast cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pharmexa A/S
- 入组人数
- 60
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
- •Histological proven adenocarcinoma of the breast.
- •Locally advanced or metastatic disease.
- •Centrally confirmed HER-2 overexpression by either a score 3+ by DAKO HercepTest TM(DakoCytomation) or a positive DAKO HER2 FISH pharmDx TM (DakoCytomation) test result on either the primary tumour or metastasis.
- •At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST).
- •Age more than or equal to 18 years and less than or equal to 80 years.
- •Life expectancy more than or equal to 6 months.
- •An Eastern Cooperative Oncology Group (ECOG) performance score of
- •Signed written informed consent prior to trial entry.
- •Willing and able to comply with the protocol for the duration of the trial.
- •No more than two prior chemotherapy regimens for locally advanced/metastatic disease (adjuvant chemotherapy after primary therapy is not counted as a regimen).
- •No more than three prior lines of endocrine treatment for locally advanced/metastatic disease
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women of child-bearing potential not using a reliable and appropriate contraceptive method. Pregnant and lactating women. Women of childbearing potential with either a positive or no pregnancy test at screening.
- •Patients who have received chemotherapy or other immunosuppressive therapy within 4 weeks prior to start of study treatment.
- •Patients who have received hormonal therapy within 4 weeks of starting study treatment.
- •Radiotherapy involving more than 25% of the bone marrow given within 3 months before inclusion in the study.
- •Patients who have previously been treated at any time with any HER-2 based anticancer vaccine.
- •Patients who have been treated with any other anticancer vaccine within 1 year of starting study treatment.
- •Patients who have previously been treated with Herceptin® (trastuzumab) or any other agents, commercially available or investigational, that target the HER-2 axis.
- •Concurrent immunosuppressive therapy, including, but not limited to, low dose methotrexate or cyclophosphamide, corticosteroids (with the exception of topically applied/inhaled steroids). Concurrent anti-tumour treatment.
- •Other cancers than breast cancer, except for basal cell carcinoma of the skin and in situ carcinoma of cervix.
- •Patients with history of significant cardiovascular disease or left ventricular ejection fraction (LVEF) <50%,
- •determined by echocardiogram or multiple gated acquisition (MUGA) scans.
- •Uncontrolled hypertension.
- •Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment.
- •Known infection of human immunodeficiency virus (HIV).
- •History of or co-existing severe auto-immune diseases or other diseases which qualify as auto-immune in origin.
- •Significantly impaired immune function as judged by the investigator.
- •Patients with abnormal baseline haematology values, abnormal baseline liver function tests, known renal dysfunction or abnormal serum creatinine values.
- •A history or clinical evidence of central nervous system (CNS) metastases.
- •Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the patient or the trial.
研究者
相似试验
进行中（未招募）
不适用
A Phase II trial evaluating the immunological and clinical efficay and safety of HER-2 Protein Autovac(TM) monotherapy in patients with metastatic breast cancer - NAFemale patients with histologically proven metastatic or locally advanced breast cancer who have HER-2 overexpression in the primary tumour and/or a metastatic lesion.EUCTR2004-000838-36-HUPharmexa A/S60
进行中（未招募）
1 期
AHealthy volunteersMedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865EUCTR2021-000509-26-FRInserm-ANRS300
进行中（未招募）
1 期
Safety and immunogenicity of RNA-based vaccines against SARS-CoV-2 variants in healthy participantsProtection against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2).MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.0Level: HLTClassification code 10084510Term: Coronavirus infectionsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 23.1Level: LLTClassification code 10084529Term: 2019 novel coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-003458-22-DEBioNTech SE1,470
未知
2 期
DNK-651-3JPRN-jRCT2080223664DENKA SEIKEN CO.,LTD.500
招募中
不适用
TaMoVaC IIPACTR201211000435126Swedish Institute for Infectious Disease Control198