EUCTR2012-002214-38-FR进行中（未招募）1 期
A PHASE II RANDOMIZED STUDY OF DOCETAXEL WITH OR WITHOUT NINTEDANIB (BIBF-1120) IN PATIENT RECEIVING A SECOND-LINE OF CHEMOTHERAPY FOR HER NEGATIVE, METASTATIC OR LOCALLY RECURRENT BREAST CANCER - VAROCE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •Age = 18 years old
- •Histologically or cytologically confirmed adenocarcinoma of the breast
- •Locally recurrent or metastatic disease
- •HER 2 negative status
- •Relapsing after a first line chemotherapy for locally recurrent or metastatic disease
- •Prior first line chemotherapy not containing Docetaxel
- •Measurable or evaluable disease according to RECIST 1.1 criteria
- •Allowed prior chemotherapy as follows :
- •-Docetaxel in the neoadjuvant or adjuvant setting is allowed provided that relapse has been observed more than 12 months after the end of docetaxel treatment
- •-Bevacizumab in 1st line is allowed with a wash-out of 3 months
- •ECOG performance status 0-1
- •Adequate bone marrow, hepatic and renal functions as evidence by the following:
- •-Hemoglobin = 10 G/100 mL
- •-Neutrophils count = 1500 /mm3
- •-Platelets = 100 000 /mm3
- •-Total bilirubin = ULN (ULN:Upper Limit of Normal)
- •-SGOT/SGPT = 1.5 x ULN (= 2.5 x ULN in case of hepatic metastasis)
- •-Creatinin clearance = 45 ml/min or creatinin = 1.5 x ULN
- •-Proteinuria < NCI CTC-AE grade 2
- •Coagulation parameters: International normalised ratio (INR) = 2, prothrombin time (PT) and partial thromboplastin time (PTT) = 50% of deviation of institutional ULN
- •Effective contraception for patients (male and female) of reproductive potential during their entire participation in the study and during 3 months after the last administration of Nintedanib or Docetaxel
- •Negative pregnancy test (serum beta-HCG) within 1 week prior to start of study treatment in females of reproductive potential
- •Patient covered by government health insurance
- •Signed and dated written informed consent prior to admission to the study in accordance with ICH-GCP guidelines and to the local legislation
- •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
- •Concomitant hormone therapy for metastatic breast cancer
- •Patients with dysphagia, or inability to swallow the tablets
- •Other serious illness or medical conditions: Cardiac disease
- •Unstable diabetes
- •Uncontrolled hypercalcemia
- •Pregnancy or breast feeding woman
- •Unable for medical follow-up (geographic, social or mental reasons)
- •Prior treatment with Nintedanib or any other VEGFR inhibitor or stratify if trial aims to establish anti-angiogenic retreatment
- •Known hypersensitivity to the trial drugs , to their excipients or to contrast media
- •Contra indication to the use of the backbone treatment and to the comparator
- •Active brain metastases (e.g. stable for <4 weeks, no adequate previous treatment with radiotherapy, symptomatic, requiring treatment with anti-convulsants; dexamethasone therapy will be allowed if administered as stable dose for at least one month before randomisation)
- •Leptomeningeal disease
- •Radiographic evidence of cavitary or necrotic tumors
- •Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of major blood vessels
- •History of clinically significant haemorrhagic or thromboembolic event in the past 6 months
- •Known inheritated predisposition to bleeding or thrombosis
- •Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina, history of infarction within the past 12 months prior to start of study treatment, congestive heart failure > NYHA II, serious cardiac arrhythmia, pericardial effusion)
- •Other malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervix
- •Active serious infections in particular if requiring systemic antibiotic or antimicrobial therapy
- •Active or chronic hepatitis C and/or B infection
- •Active alcohol or drug abuse
- •Significant weight loss (> 10% of BW) within past 6 months prior to inclusion into the trial
研究者
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