A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 46
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment
详细描述
The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment that would have the theoretical advantage of being well tolerated and more effective than chemotherapy alone even after an anti-aromatase therapy.
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
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years.
- •Histologically proven breast cancer.
- •Progesterone and /or oestrogene receptors positive.
- •HER2 negative on primary tumour.
- •Patient taking hormonotherapy, in progression, already treated by at least one line of anti-aromatase non-steroidal hormonotherapy and by at least on line of chemotherapy.
- •Patient having to begin a second or third line of chemotherapy.
- •Presence of one or several measurable(s) or assessable(s) metastatic lesion(s).In case of isolated bone lesion (s): need to have a non-irradiated with an osteolytic component for be considered as lesion (s) target (s) and having an elevation of the CA15-
- •Post menopausal woman.
- •ECOG 0, 1 or
- •Adequate biological function.
- •Neutrophil ≥ 1,5.E9/L
- •Platelets ≥ 100.E9/L
- •Creatinine clearance ≥ 30 mL/min
- •Total bilirubin ≤ 1,5 x the upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2,5 x ULN
- •ALT, AST ≤ 1,5 x ULN in the absence of liver metastases or ≤ 3 x ULN if liver metastases.
- •Patient with a life expectancy greater than 3 months.
- •Signed informed consent before enrollment.
- •affiliation to a social security scheme
排除标准
- •Patient with located or single metastatic tumoral relapse, accessible to a surgical treatment.
- •Patient having already received more 2 lines of chemotherapy for metastatic or advanced decease
- •Patient having already received a treatment by Navelbine®
- •Patient requiring an immediate located radiotherapy for analgesic action
- •Patient with non-irradiated cerebral or symptomatic metastasis, symptomatic pulmonary carcinomatosis lymphangitis
- •Simultaneous administration of another chemotherapy hormonotherapy or anti-tumoral drug
- •Patient having already received another treatment ongoing evaluation within the 30 days before the screening visit
- •Known positive serology HIV
- •Previous cancer within 5 years before the entry in the study, excepted an in situ carcinoma of the cervix or a spino or basal cell carcinoma of the skin or a nonmelanoma skin cancer with an adequate treatment.
- •Any serious concomitant pathology and / or uncontrolled could compromise participation in the study (including uncontrolled diabetes, uncontrolled hypertension, severe infection, profound malnutrition, unstable angina or congestive heart failure - class III or IV according to the New York Heart Association - ventricular arrhythmias, progressive coronary artery disease, myocardial infarction within the last six months, chronic liver or kidney disease, a progressive ulceration of the digestive tract above, CNS disorders).
- •Disorder of gastrointestinal function (GI) or pathology likely to significantly interfere with the absorption of Navelbine, of Letrozole or Anastrozole (eg. Ulcerative disease, uncontrolled nausea, vomiting, diarrhea, syndrome malabsorption, or resection of the small intestine).
- •Known hypersensitivity to letrozole, anastrozole, vinorelbine or other vinco-alkaloids or any other component.
- •Patient with fructose intolerance, galactose, a Lapp lactase deficiency or malabsorption of glucose and galactose (rare hereditary disease).
- •Patient with a history of poor compliance with medical treatment.
- •Patient can not be monitored regularly for family reasons, geographical, social or psychological.
- •Patient with altered mental status would not allow him to understand the study or give informed consent .
研究组 & 干预措施
Vinorelbine
Vinorelbine (metronomic) alone 3 times per week ( mondays, wednesdays, Fridays or Thursdays, Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity.
干预措施: Vinorelbine (Drug)
Vinorelbine+Anastrozole or Letrozole
Vinorelbine metronomic 3 times per week (mondays, wednesdays, Fridays or Thursdays,Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity.
And:
Letrozole 2,5 mg every day or Anastrozole 1 mg every day. Until progression of disease or toxicity
干预措施: Vinorelbine (Drug)
Vinorelbine+Anastrozole or Letrozole
Vinorelbine metronomic 3 times per week (mondays, wednesdays, Fridays or Thursdays,Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity.
And:
Letrozole 2,5 mg every day or Anastrozole 1 mg every day. Until progression of disease or toxicity
干预措施: Letrozole (Drug)
Vinorelbine+Anastrozole or Letrozole
Vinorelbine metronomic 3 times per week (mondays, wednesdays, Fridays or Thursdays,Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity.
And:
Letrozole 2,5 mg every day or Anastrozole 1 mg every day. Until progression of disease or toxicity
干预措施: Anastrozole (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: up to 6 months
Proportion of progression or death
次要结局
- overall survival(up to 2 years)
- Toxicity according to criteria NCI CTAEv4.03(up to 2 years)
- Evaluation of partial and complete response rate by RECIST 1.1(up to 6 months)
- clinical benefit after 24 weeks of treatment(up to 24 weeks)
- health-related quality of life(up to 2 years)
- duration of response(up to 6 months)