EUCTR2020-001938-35-DE进行中（未招募）1 期
AIRE: – ASSESSING IMMUNORESPONSE POST ERIBULIN: ERIBULIN AND IMMUNOGENICITY IN ADVANCED BREAST CANCER – A PROSPECTIVELY RANDOMIZED PHASE IV STUDY - AIRE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
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
- •Patients will be treated according to the SmPC of eribulin or paclitaxel respectively. No patients will be treated which could not be treated with these substances outside this Phase IV trial.
- •1.Written informed consent prior to beginning of trial specific procedures
- •2.Subject must be female and aged = 18 years on day of signing informed consent
- •3.ECOG 0-1
- •4.Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion. Human epidermal growth factor receptor 2 (HER2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio = 2.2), or IHC 0 or IHC 1+.
- •5.Indication for chemotherapy
- •6.Previous therapy with at least one chemotherapy line
- •7.Target lesion (RECIST 1.1)
- •8.Adequate organ function defined as:
- •a.Creatinine Clearance > 50 ml/min
- •b.ANC = 1500 /µL
- •c.Thrombocytes > 100 000 /µL
- •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 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •The subject must be excluded from participating in the trial in following cases:
- •1.HER2 positive disease
- •2.Indication for an anti-hormone treatment
- •3.Active infection requiring systemic therapy.
- •4.Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs.
- •5.History of primary or acquired immunodeficiency (including allogenic organ transplant).
- •6.Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis).
- •7.Severely impaired liver function (Child Pugh C)
- •8.Hypersensitivity to study medication or any of its components
- •9.Neuropathy (PNP) > Grade 2 (CTCAE 5.0)
- •10.Congenital long QT syndrome
- •11.Preexisting concomitant use of strong CYP3A4, CYP2C9 and CYP2C8 inhibiting or inducing drugs
- •12.Life expectancy of less than three months
- •13.Pregnancy (contraception is required according to contraceptive guidance)
- •14.Lactation
- •15.Known history of following infections:
- •a.Human immunodeficiency virus (HIV)
- •b.History of acute or chronic Hepatitis B or Hepatitis C
- •16.Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- •17.Does not agree to blood collection
- •Additional exclusion criteria in case of planned treatment with capecitabine
- •18.Known DPD deficiency (specific screening is encouraged but not mandatory)
- •19.Treatment with nucleoside analogues including brivudine within 28 days before study enrollment or requirement for concomitant antiviral treatment with brivudine or analogues
研究者
相似试验
进行中（未招募）
不适用
(Maraviroc ENHancement of Immunological Response): A pilot study of maraviroc as an add-on in patients with reduced CD4 cell count despite full viral suppression - MENHIREUCTR2010-019518-25-ITAZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)
招募中
不适用
MOODSTRATIFICATION IMMUNOSTRATAPremature immune ageing to predict the effect of physical training intervention, in mood disordersF32F33F31Depressive episodeRecurrent depressive disorderBipolar affective disorderDRKS00022887niversitätsklinikum Münster500
已完成
不适用
ASER ASSISTED IMMUNOTHERAPY-C50 Malignant neoplasm of breastMalignant neoplasm of breastC50PER-091-09IMMUNOPHOTONICS / THE SOURCE SAC,10
进行中（未招募）
1 期
Evaluation of immunological response following a revaccination with a non-conjugated pneumococcal vaccine boosted or not by a conjugated pneumococcal vaccine in splenectomised patients (SPLENEVAC-2)Asplenic patients at risk for invasive pneumococcal diseasesMedDRA version: 20.0Level: PTClassification code 10041642Term: SplenectomySystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2018-003068-29-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)56
Enrolling By Invitation
不适用
Follow-up: Immunogenicity according to reactogenicity of Covid-19 vaccinesReactogenicity and immunogenicity of ComirnatyDRKS00026982niversity Medical Center Regensburg76