EUCTR2012-003442-32-FR进行中（未招募）1 期
AN OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE III STUDY IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER RESPONDING TO FIRST LINE TREATMENT WITH INTRAVENOUS TRASTUZUMAB FOR AT LEAST 3 YEARS AND INVESTIGATING PATIENT PREFERENCE FOR SUBCUTANEOUS TRASTUZUMAB
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
- ROCHE SAS
- 入组人数
- 200
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
- All
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.ECOG performance status 0–2
- •5.Hormonal therapy will be allowed as per institutional guidelines
- •6.Prior use of anti-HER2 therapy will be allowed
- •7.LVEF of = 50% measured by ECHO or MUGA scan prior to first dose of trastuzumab, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrolment
- •8.HER2-positive disease IHC3+ or ISH positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay, or documented HER2 status, as the patients in this study are long responders
- •9.Histologically or cytologically confirmed locally advanced or mBC with at least one measurable lesion
- •10.Documented history of histologically or cytologically confirmed mBC
- •11.mBC patients on treatment with first line trastuzumab IV free of disease progression for at least 3 years (confirmed by standard local procedures according to disease history and standard practice)
- •12.Patient registered with or beneficiary from social security system
- •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
- •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. Patients with previous DCIS of the breast are also eligible for the study
- •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 CHF, high-risk uncontrolled arrhythmias, angina pectoris requiring medication , clinically significant valvular disease, evidence of transmural infarction on ECG, diagnosed poorly controlled hypertension
- •5.Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •6.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
- •7.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
- •8.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
- •9.Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin®, or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
- •10.Patients assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol
- •11.Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months
- •12.Inadequate organ function, evidenced by the following laboratory results:
- •a)Absolute neutrophil count < 1,500 cells/mm3
- •b)Platelet count < 100,000 cells/mm3
- •c)Hemoglobin < 9 g/dL
- •d)Total bilirubin > 1.5 × ULN (unless the patient has documented Gilbert’s syndrome)
- •e)AST (SGOT) or ALT (SGPT) > 2.5 × ULN ( > 5 × ULN in patients with liver metastases)
- •f)Alkaline phosphatase levels > 2.5 × the ULN ( > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone metastases)
- •g)Serum creatinine > 2.0 mg/dL or 177 µmol/L
研究者
相似试验
进行中（未招募）
不适用
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE III STUDY OF SECOND-LINE CHEMOTHERAPY WITH OR WITHOUT BEVACIZUMAB IN METASTATIC COLORECTAL CANCER PATIENTS WHO HAVE RECEIVED FIRST-LINE CHEMOTHERAPY PLUS BEVACIZUMAB - BEBYPMETASTATIC COLORECTAL CANCER PATIENTSMedDRA version: 9.1Level: LLTClassification code 10052358Term: Colorectal cancer metastaticEUCTR2007-002886-11-ITG.O.N.O. - GRUPPO ONCOLOGICO NORD OVEST
进行中（未招募）
1 期
A comparative study of MPDL3280A versus chemotherapy in patients with advanced bladder cancer.EUCTR2014-003231-19-FRF. Hoffmann-La Roche Ltd776
进行中（未招募）
1 期
A Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients with Treatment-Naïve Advanced or Recurrent (Stage IIIB Not Amenable For Multimodality Treatment) or Metastatic (Stage IV) Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Containing TherapyEUCTR2015-004105-16-DKF. Hoffmann-La Roche Ltd453
已完成
不适用
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF MPDL3280A (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN + PACLITAXEL OR MPDL3280A IN COMBINATION WITH CARBOPLATIN + NAB PACLITAXEL VERSUS CARBOPLATIN + NAB-PACLITAXEL IN CHEMOTHERAPY-NAÏVE PATIENTS WITH STAGE IV SQUAMOUS NON-SMALL CELL LUNG CANCERPER-028-15F. HOFFMANN-LA ROCHE LTD.,6
进行中（未招募）
1 期
A study comparing the clinical benefit and side effects of Atezolizumab to docetaxel in patients with lung cancer who have not benefited from platinum-containing cancer drugs.EUCTR2013-003331-30-SEF. Hoffmann-La Roche Ltd1,225