EUCTR2016-000284-17-DE进行中（未招募）1 期
Phase II study of metronomic treatment with daily oral vinorelbine as first-line chemotherapy in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy (VinoMetro). - VinoMetro
niversitätsmedizin Mainz0 个研究点目标入组 45 人开始时间: 2016年8月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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 (personally dated and signed) informed consent prior to the per¬for¬man¬ce of any trial specific procedure
- •2. Absence of any psychological, familial, sociological or geographical con¬dition potentially hampering compliance with the study protocol and/or the follow-up schedule
- •3. Female patient = 18 years of age
- •4. ECOG performance status 0-1, which the investigator assesses as being stable at time of screening
- •5. Estimated life expectancy = 16 weeks
- •6. Histologically confirmed adenocarcinoma of the breast
- •7. Documented locally advanced or metastatic disease, previously untreated by palliative chemotherapy and not amenable to any curative treatment
- •8. Hormone receptor positive disease determined by = 1% positive stained cells for oestrogen and/or progesterone receptor by immunohistochemistry on the primary tumour or on a metastatic site
- •9. HER2-negative disease (assessed by 0-1+ IHC or 2+ IHC with negative FISH or CISH) on the primary tumour or on a metastatic site
- •10. Availability of archival (from the most recently obtained sample) or fresh tumour tissue from patients included in the trial for the analysis of relevant me¬tro¬¬nomic biomarkers; one tumour block (preferred) or a minimum of 12 (recommended: 15) unstained slides to be provided
- •11. Relapse = 12 months from end of adjuvant hormonal therapy or pro¬gres¬sion during/after = 1 line of endocrine therapy in the metastatic set¬ting and/or no longer candidate for further endocrine therapy
- •12. Prior (neo-)adjuvant chemotherapy is allowed, if the interval between end of chemotherapy and date of registration is > 12 months
- •13. Prior treatment with everolimus and/or palbociclib in the frame of hormonal therapy is allow¬ed
- •14. Complete staging before registration (CT/MRI thorax and CT/MRI abdo¬men/pelvis = 28 days before registration; bone scan = 3 months before registra¬tion)
- •15. Presence of = 1 measurable lesion as per RECIST 1.1, which has not been previously irradiated
- •16. Adequate bone marrow, hepatic and renal function as defined by the following laboratory values:
- •Absolute neutrophil count (ANC) = 1,500/mm3
- •Platelet count = 100,000/mm3
- •Haemoglobin = 10 g/dL
- •Total serum bilirubin = 1.5 x ULN (= 3 x ULN in case of liver metasta¬s¬es)
- •Liver transaminases = 2.5 x ULN (= 5 x ULN in case of liver metasta¬s¬es)
- •Alkaline phosphatase = 5 x ULN
- •Creatinine = 1.5 x ULN (creatinine clearance should be assessed based on the Cock¬roft-Gault-formula in case of borderline values and should then be = 50 ml/min)
- •17. Women of childbearing potential must be using a medically accepted method of contraception to avoid pregnancy during 2 months preceding registration, throughout the study period and up to 3 months after last dose of study treatment in such a manner that the risk of pregnancy is mini¬mised; reliable contraception comprises sexual abstinence, male sterilization or double barrier methods (e.g. a combination of male condom with diaphragm).
- •18. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study treatment
- •19. Ability of the patient to understand the character and the individual consequences of this clinical 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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. No recovery to = Grade (G)1 side effects (exception: alopecia) of any prior anti-neoplastic treatment
- •2. Aggressive locally advanced or metastatic breast cancer disease requiring systemic combination therapy
- •3. Known or suspected CNS and/or leptomeningeal involvement
- •4. Current peripheral neuropathy = G2
- •5. Dysphagia or inability to swallow oral medication
- •6. Malabsorption syndrome or disease significantly affecting GI-function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine
- •7. Other serious illness or medical condition, such as but not limited to:
- •Clinically significant cardiac disease or impaired cardiac function (such as: congestive heart failure requiring treatment (NYHA = II); LVEF <50%; significant cardiac arrhythmia; atrial fibrillation; conduction abnormality such as congenital long QT syndrome or high grade/complete AV-blockage; acute coronary syndrome including myocardial infarction, unstable angina pectoris, coronary artery bypass graft, coronary angioplasty or stenting, if < 3 months prior to registration; QTcF >480 msec at screening)
- •Uncontrolled hypertension (>140/100 mmHg at rest (average of 3 consecutive readings))
- •Unstable diabetes mellitus
- •Uncontrolled hypercalcemia
- •Clinically significant active infections (current or within the last 2 weeks prior to registration)
- •Previous organ allograft
- •8. Prior treatment with vinorelbine or other vinca alkaloids
- •9. Concomitant endocrine therapy (e.g. tamoxifen, aromatase inhibitors, fulvestrant) for advanced breast cancer
- •10. Concomitant use of yellow-fever vaccination or other attenuated life vaccine
- •11. Concomitant treatment with strong CYP3A4-inhibitors or strong CYP3A4-inducers (discontinuation before registration is acceptable, if medically feasible and ethically acceptable)
- •12. Necessity to undergo long-term oxygen therapy
- •13. Major surgery = 28 days prior to registration and/or no recovery from side effects of such therapy to baseline condition or = G1
- •14. Radiotherapy = 28 days prior to registration, no recovery from side effects of such therapy to baseline condition or = G1 and/or irradiation of =30% of bone marrow
- •15. Known hypersensitivity to vinca alkaloids, soy, peanut or any of the excipients contained in the oral vinorelbine capsules
- •16. Participation in another clinical trial with any investigational drug = 30 days prior to registration
- •17. History of another malignancy within the past 5 years prior to registration, except cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix
- •18. Pregnant or nursing (lactating) woman
研究者
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