NCT01658462已完成2 期
A Phase II Randomized Study of Docetaxel With or Without NINTEDANIB (BIBF-1120) in Patient Receiving a First or Second-line of Chemotherapy for HER Negative Metastatic or Locally Recurrent Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 12
- 主要终点
- Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)
研究概览
简要总结
National, randomized, unblinded, phase IIb trial with 2 strata: First-line chemotherapy / Second-line chemotherapy for locally recurrent or metastatic breast cancer.
详细描述
Patients will be stratified at randomization according to first-line chemotherapy / Second-line chemotherapy for metastatic or locally recurrent breast cancer
Treatment until progression or unacceptable toxicity Visits are planned every 3 weeks during treatment and every 3 months after end of treatment or patient's withdrawal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
- •Requiring a first or a second-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 4 weeks, with recovery to NCI-CTCAE v3.0 toxicity
- •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)
- •Serum alkaline phosphatase ≤ 2.5 x ULN
- •Creatinin clearance ≥ 45 ml/min or creatinin ≤ 1.5 x ULN
- •Proteinuria < CTCAE 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) with 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) performed within 1 week prior to start of study treatment in females with 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
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
- •Known hypersensitivity to the trial drugs , to their excipients, to peanut, to soya 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 inherited 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
研究组 & 干预措施
Arm B
Active Comparator
Docetaxel + increase of the dose
干预措施: Docetaxel (Drug)
Arm A
Experimental
Docetaxel + Nintedanib
干预措施: Docetaxel (Drug)
Arm B
Active Comparator
Docetaxel + increase of the dose
干预措施: Docetaxel: increase of the dose (Drug)
Arm A
Experimental
Docetaxel + Nintedanib
干预措施: Nintedanib (Drug)
结局指标
主要结局
Progression free survival (PFS) in patients receiving Docetaxel + Nintedanib treatment (Arm A) compared to Docetaxel alone (Arm B)
时间窗: baseline, every 9 weeks (or 3 cycles), up to 6 months
6-months progression free disease
次要结局
- response rate(baseline, every 9 weeks (or 3 cycles), up to 6 months)
- overall survival(up to 2 years)
- safety profile of Nintedanib(before each cycle, 3 weeks after the last dose or at the end of study)
- biological markers levels in tumors and endothelial cells(baseline, every 9 weeks (or 3 cycles), up to 6 months)
- biological markers in patient serum(baseline, every 9 weeks (or 3 cycles), up to 6 months)
- quality of life by QLQ-C30 and additionnel module BR23(baseline, every 9 weeks (or 3 cycles), up to 6 months)
研究者
研究点 (12)
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