EUCTR2009-017788-40-FR进行中（未招募）不适用
Etude de phase II randomisée multicentrique évaluant l'efficacité d’estramustine phosphate (Estracyt ®) chez des patientes présentant un cancer du sein métastatique HER2- / RH+ ayant déjà reçu un traitement par inhibiteur d’aromatase - EFESE
CRLCC Alexis Vautrin0 个研究点开始时间: 2010年9月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Post-menopausal women or women receiving LHRH analogs
- •Histologically confirmed metastatic breast cancer RH+
- •Measurable metastatic breast cancer (modified RECIST criteria) or not mesurable but evaluable
- •Recurrence:
- •- being treated with aromatase inhibitors (AIs)
- •- less than one year after adjuvant treatment by AIs
- •- after progression of the metastatic cancer in patients receiving AIs following positive response during at least 6 months
- •Performance index = 2 (OMS)
- •Haematological test: polynuclear neutrophiles = 1.5 × 109 /L, haemoglobin = 9 g/dL, blood platelet = 100 × 109 /L
- •Hepatic function: albumin = 2.5 g/dL, serum bilirubin = 1.5 × N (except if Gilbert’s Syndrome) , aminotransferases = 3 × N (= 5 × N if hepatic metastases)
- •Renal function: serum creatinine = 1.5 mg/dL or clearance of creatinine = 40 ml/min
- •Women without endometrial pathology
- •Patient who agrees, according to the investigator, to comply with the study requirements
- •Signed informed consent
- •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
- •Women aged < 18
- •Pre-menopausal, pregnant or lactating females
- •Patient who should exclusively be treated by chemotherapy
- •Women previously treated with chemotherapy but not by AIs
- •Women previously treated by tamoxifene for their metastatic breast cancer
- •HER2+ tumour
- •Concurrent anti-cancer treatment (chemotherapy, surgery, immunotherapy, biological therapy and tumour embolism)
- •Concurrent treatment with protocol-defined prohibited medications
- •Malabsorption syndrome , significant digestive dysfunction, gastrectomy, jejunectomy, hemorrhagic recto colon
- •Concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
- •Any pathology, including severe psychiatric or psychologic disease that may harm patient’s safety or participation in the study
- •Serious or not cured or unstable toxicity due to the administration of another drug being involved in clinical trials
- •Uncontrolled cardiovascular pathologies
- •Previous cardiovascular disease of type deep vein thrombosis or pulmonary embolism recorded within one year before the inclusion date
- •Active uncontrolled infection
- •Risk of thromboembolic events such as:
- •- personal history of any thromboembolic event
- •- antiphospholipid antibody
- •- family history of thrombophilia
- •Participation to a clinical trial at least 4 weeks prior the start of the study
研究者
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