NCT01520103已完成2 期
Randomized Phase II Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced 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
- 139
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of this study is Examination of the superiority of a combination of vinorelbine with the mTOR Inhibitor Everolimus vs. vinorelbine monotherapy for second-line treatment in advanced breast cancer.
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
- •1 .Dated and signed patient informed consent before start of any in the protocol specified procedures
- •Histologically or cytologically confirmed Her2/neu negative, metastatic or locally advanced breast cancer, including inoperable local relapse, with measurable or non-measurable lesions for which
- •a palliative second line chemotherapy is indicated. Antihormone palliative pretreatments do not count as separate treatment lines
- •treatment with anthracycline and/or taxanes has failed or is not suitable
- •which cannot be adequately treated by operation or radiotherapy on its own
- •An exclusive anti-hormone therapy is not indicated for the patient
- •ECOG Performance Status of 0-2
- •Women >= 18 years of age
- •Life expectancy of at least 12 weeks
- •Adequate bone marrow, liver and renal function (according to SmPC of Vinorelbine, Afinitor®) based on laboratory assessments raised within 7 days prior to start of study treatment:
- •Haemoglobin >= 9.0 g/dl
- •Absolute neutrophil count (ANC) >= 2/mm³
- •Thrombocytes >= 100/µl
- •INR >= 2
- •Serum bilirubin =< 1.5x upper limit of normal ( in patients with known Gilbert syndrome, total bilirubin =< 3x upper limit of normal, with direct bilirubin =< 1.5x upper limit of normal
- •ALT and AST =< 2.5x upper limit of normal (=< 5x upper limit of normal in subjects with liver metastases)
- •Serum cholesterol =< 300 mg/dl or 7.75 mmol/l and triglycerides =< 2.5x upper limit of normal (with lipid lowering drugs permitted)
- •Serum creatinin =< 2x upper limit of normal
- •Documentation of a negative pregnancy test in women of childbearing potential within 7 days prior to start of study. Sexual active pre-menopausal women are required to use adequate contraception throughout the duration of the study, except for oestrogen containing contraceptives
排除标准
- •Previous treatment with Vinorelbine or an inhibitor of mTOR
- •Treatment with other study medication within 28 days before start of treatment
- •Patients who have received prior radiotherapy to ≥ 25% of the bone marrow
- •Other tumours in the previous 5 years with exception of an adequately treated basal cell carcinoma of the skin or a preinvasive cervix carcinoma
- •Simultaneous use of known CYP3A4 inducers (e.g. Phenytoin, Rifampicin) or inhibitors of this enzyme (e.g. Itraconazole, Ketoconazole), therefore also use of mistletoe, St John's wort or grapefruit juice
- •Patients to whom at least one of the conditions applies:
- •Substance abuse
- •medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- •Legal incapacity or limited legal capacity
- •Subjects who are unable to take oral medication
- •Any condition that could jeopardise the safety of the patient and their compliance in the study as judged by the investigator
- •History of cardiac dysfunction including one of the following:
- •Myocardial infarction by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function
- •History of documented congestive heart failure (NYHA ≥ 3)
- •Documented cardiomyopathy
- •Known HIV infection or chronic hepatitis B or C or history of hepatitis B / C
- •Active clinically relevant infection (> grade 2 NCI-CTC Version 4.03)
- •Clinical or radiological detection of CNS metastases
- •Patients receiving concomitant immunosuppressive agents or chronic use of corticosteroids at the time of study entry except in cases outlined below:
- •topical applications (e.g. rash,) inhaled sprays, (e.g. obstructive airway diseases) eye drops or local injections (e.g. intraarticular) are allowed
- •Active bleeding diathesis or an oral anti-vitamin K medication (except low-dose warfarin and aspirin or equivalent, as long as the INR ≤ 2)
- •Kidney function disorder requiring dialysis
- •Seriously impaired liver function (Child-Pugh, class C)
- •Known hypersensitivity reaction to Vinorelbine or Everolimus
- •Pregnant or breast-feeding subjects
研究组 & 干预措施
Vinorelbin and Everolimus
Experimental
干预措施: Vinorebine, Everolimus (Drug)
standard therapy
Other
Vinorelbin
干预措施: Vinorelbine (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Assessment over 36 months, minimum 12 month
Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse or death.
次要结局
- Response rate (CR, PR)(36 months)
- Safety and tolerability(Assessment over 36 months)
- Rate of Progression Free Survival after 6 months (6 months PFSR)(Assessment over 36 months)
- Overall survival (OS)(36 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study of Gemcitabine and Vinorelbine in Soft Tissue SarcomasSarcoma, Soft TissueNCT00134641Dana-Farber Cancer Institute40
已完成
不适用
Randomised phase II trial comparing vinorelbine and capecitabine with docetaxel and capecitabine chemotherapy for metastatic breast cancerBreastCancerBreast cancerISRCTN66842537Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)100
已完成
2 期
Meinetenance chemotherapy in lung cancerMalignant neoplasm of lung and brochous.Malignant neoplasm of bronchus and lung including: main bronchus, upper lobe bronchus , Middle lobe bronchus, Lower lobe, bronchus or Bronchus or lung, unspecified.code:C34IRCT2015060822610N1Investigator100
已完成
1 期
Phase I study of Vinorelbine(VNR) and S-1 combination therapy for the elderly patients with advanced non-small-cell lung cancer.advanced non-small-cell lung cancerJPRN-UMIN000026093Tokyo Metropolitan Tama Medical Center Department of respiratory medicine and clinical oncology9
已完成
1 期
Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast CancerMetastatic Breast CancerNCT00706069Hellenic Oncology Research Group40