EUCTR2004-000838-36-HU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 - NA
适应症
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
- •Female breast cancer patients who fulfil the following criteria will be eligible for inclusion in the trial:
- •1.Histological proven adenocarcinoma of the breast.
- •2.Locally advanced or metastatic disease.
- •3.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. The HER-2 expression status of the patient MUST BE confirmed by the central laboratory before enrolment and the patient’s first vaccination with HER-2 Protein AutoVac(TM).
- •4.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST).
- •5.Age less than or equal to 18 yearsand less than or equal to 80 years
- •6.Life expectancy more than or equal to 6 months.
- •7.Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- •8.Signed written informed consent prior to trial entry.
- •9.Willing and able to comply with the protocol for the duration of the trial.
- •10.No more than two prior chemotherapy regimens for locally advanced/metastatic disease (adjuvant chemotherapy after primary therapy is not counted as a regimen).
- •11.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
- •Patients will be excluded from the trial should they meet one or more of the following criteria:
- •1.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.
- •2.Patients who have received chemotherapy or other immunosuppressive therapy within 4 weeks prior to start of study treatment.
- •3.Patients who have received hormonal therapy within 4 weeks of starting study treatment.
- •4.Radiotherapy involving more than 25% of the bone marrow given within 3 months before inclusion in the study.
- •5.Patients who have previously been treated at any time with any HER-2 based anticancer vaccine.
- •6.Patients who have been treated with any other anticancer vaccine within 1 year of starting study treatment.
- •7.Patients who have previously been treated with Herceptin® (trastuzumab) or any other agents, commercially available or investigational, that target the HER-2 axis.
- •8.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.
- •9.Other cancers than breast cancer, except for basal cell carcinoma of the skin and in situ carcinoma of cervix.
- •10.Patients with history of significant cardiovascular disease or left ventricular ejection fraction (LVEF) less than 50%, determined by echocardiogram or multiple gated acquisition (MUGA) scans.
- •11.Uncontrolled hypertension.
- •12.Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment.
- •13.Known infection of human immunodeficiency virus (HIV).
- •14.History of or co-existing severe auto-immune diseases:
- •-Auto-immune neutropaenia.
- •-Auto-immune thrombocytopaenia.
- •-Haemolytic anaemia.
- •-Systemic lupus erythematosus.
- •-Sjogren syndrome.
- •-Scleroderma.
- •-Myasthenia gravis.
- •-Goodpasture syndrome.
- •-Addison’s disease.
- •-Hashimoto’s thyroiditis.
- •-Active Graves’ disease.
- •-Other diseases which qualify as auto-immune in origin.
- •14.Significantly impaired immune function as judged by the investigator.
- •15.Patients with any of the following abnormal baseline haematology values:
- •-Haemoglobin less than 10 g/dL (6.2 mmol/L).
- •-White blood cells (leukocytes) less than 3 x 109/L.
- •-Lymphocytes less than 1 x 109/L.
- •-Platelets less than 100 x 109/L.
- •16.Patients with any of the following abnormal baseline liver function tests:
- •-Serum bilirubin more than 1.5 x upper normal limit (UNL), except if the patient has a documented diagnosis of Gilbert’s syndrome.
- •-g-Glutamyltransferase (GGT) more than 2.5 x UNL (or 5 x UNL in case of liver metastases).
- •-Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 2.5 x UNL (or 5 x UNL in case of liver metastases).
- •17.Known renal dysfunction or the following abnormal baseline values:
- •-Serum creatinine more than 1.5 x UNL.
- •18.A history or clinical evidence of central nervous system (CNS) metastases.
- •19.Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the patient or the trial.
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