EUCTR2012-001201-24-ES进行中（未招募）1 期
A prospective, multicenter, single-arm, phase II study to evaluate the safety of neoadjuvant liposomal doxorubicin (Myocet®) plus paclitaxel, trastuzumab, and pertuzumab in patients with operable HER2-positive breast cancer - SOLTI Opti-HER HEART
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SOLTI
- 入组人数
- 83
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.Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures
- •2.Female patients
- •3.Age 18-74 years
- •4.ECOG Performance Status of 0 or 1
- •5.Histologically confirmed, untreated, invasive breast carcinoma eligible for primary definitive surgery
- •6.Tumor size ? 2 cm by clinical or radiological assessment
- •7.HER2-positive invasive BC, defined as: IHC 3+ in > 10% immunoreactive cells OR HER2 gene amplification by in situ hybridization (FISH, CISH), defined as a ratio of HER2 gene signals to centromere 17 ? 2.0
- •8.Known hormone receptor status or the possibility of its assessment
- •9.Adequate organ function defined as:
- •-Absolute Neutrophil Count (ANC) ? 1.5 x 109/L
- •-Hemoglobin (Hgb) ? 9 g/dL
- •-Platelets > 100 x 109/L
- •-Creatinine ? 1.6mg/dL
- •-ALT and AST ? 2.5 x ULN
- •-Alkaline phosphatase ? 5 ULN
- •-Total bilirubin ? 1.5 mg/dL
- •10.Baseline LVEF ? 55% measured by echocardiogram or MUGA scan
- •11.Negative ?-HCG pregnancy test (serum) for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after the menopause. All subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from 2 weeks before administration of the first dose of investigational product until 28 days after the last dose of investigational product.
- •12.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •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 73
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Clinical or radiologic evidence of metastatic disease at the time of study entry
- •2.Stage III inoperable BC
- •3.Prior chemotherapy, radiotherapy, or surgery for BC, other than excision of tumor in the contralateral breast, and provided that the patient did not previously receive adjuvant radiotherapy or chemotherapy
- •4.Subjects with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Subjects with other non-mammary malignancies must have been disease free for at least 5 years
- •5.Known or suspected hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances
- •6.Presence of congestive heart failure or LVEF < 55%
- •7.Clinically significant (i.e. active) cardiovascular disease, including cerebro-vascular accident (< 6 months before enrollment), unstable angina pectoris, myocardial infarction ? 6 months before enrollment, uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg), or high-risk uncontrolled arrhythmias
- •8.Uncontrolled diabetes mellitus, active peptic ulcer disease or uncontrolled epilepsy
- •9.Active uncontrolled infection at the time of enrollment
- •10.History of significant comorbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent
- •11.Use of any investigational agent or participation in another therapeutic clinical trial concurrently or in the previous 30 days before the enrollment
- •12.Patients who are pregnant or breast-feeding
- •13.Women of child bearing potential who are unable or unwilling to use acceptable contraceptive measures
- •14.Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator or designee
研究者
相似试验
进行中（未招募）
1 期
The study will evaluate the safety and efficacy of a combined therapy consisting of immuntherapy and radiation prior to radical cystectomy in patients with locally advanced urothelial bladder cancerEUCTR2018-001823-38-DETechnische Universität München, Fakultät für Medizin vertreten durch den Dekan33
已完成
2 期
A prospective, multi-centre, single arm, phase 2 assessment of the efficacy and safety of the combination of ixazomib, thalidomide and dexamethasone (ITD) for relapsed and/or refractory multiple myeloma after 1 to 3 prior lines of therapy.Cancer - MyelomaMultiple MyelomaACTRN12616000894493Professor Andrew Spencer40
进行中（未招募）
不适用
Post Hematopoietic Stem Cell TransplantatioEUCTR2016-001561-88-Outside-EU/EEAovartis Pharmaceuticals27
招募中
1 期
CAR-T cells Therapy in ALL patientsRelapsed or refractory B cell malignanciesB-ALLCAR-T cellsCell TherapyTCTR20220624004Genepeutic Bio, Co., Ltd20
进行中（未招募）
1 期
A study to assess the efficacy and safety of JCAR017, a CAR-T cell therapy, in adults with aggressive B-Cell Non-Hodgkin LymphomaAggressive B-cell Non Hodgkin Lymphoma (B-NHL)MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersMedDRA version: 23.0Level: LLTClassification code 10029593Term: Non-Hodgkin's lymphoma NOSSystem Organ Class: 100000004864EUCTR2017-000106-38-ITCELGENE CORPORATIO124