EUCTR2012-000073-23-AT进行中（未招募）不适用
An open-label, multi-center, expanded access study for postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer who have progressed following prior endocrine therapy, investigating the treatment of everolimus (RAD001) in combination with exemestane
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,200
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. Adult women (= 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy, whose disease recurred or progressed following a NSAI treatment.
- •Letrozole or anastrozole do not have to be last treatment prior to study enrollment.
- •2. Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer and/or progesterone receptor-positive (PgR+)
- •3. Postmenopausal women. Postmenopausal status is defined either by:
- •Age = 55 years and one year or more of amenorrhea
- •Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml
- •Surgical menopause with bilateral oophorectomy
- •4. Adequate bone marrow and coagulation function as shown by:
- •Absolute neutrophil count (ANC) = 1.5 109/L
- •Platelets = 100 ×109/L
- •Hemoglobin (Hgb) = 9.0 g/dL
- •5. Adequate liver function as shown by:
- •Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 ULN (or = 5 if hepatic metastases are present)
- •Total serum bilirubin = 1.5 × ULN (= 3 × ULN for patients known to have Gilbert Syndrome)
- •6. Adequate renal function as shown by:
- •Serum creatinine = 1.5 × ULN
- •7. Fasting serum cholesterol = 300 mg/dl or 7.75 mmol/L and fasting triglycerides = 2.5 × ULN. In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy or other lipid lowering drugs (eg fibrates), and when the above mentioned values have been achieved
- •8. Written informed consent obtained before any screening procedure and according to local guidelines
- •Other protocol defined inclusion criteria may apply
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1700
排除标准
- •1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
- •2. Pre-menopausal, pregnant, lactating women
- •3. Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin) or to their excipients.
- •4. Known hypersensitivity to exemestane, to the active substance or to any of the excipients.
- •5. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
- •6. Radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment.
- •7. Currently receiving hormone replacement therapy, unless discontinued prior to enrollment.
- •8. Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:
- •Prolonged systemic corticosteroid treatment during study, except for topical applications (e.g. rash),inhaled sprays (e.g. obstructive airways diseases), eye drops or local injections (e.g. intraarticular) should not be given. However, during the study:
- •short duration (<2 weeks) of systemic corticosteroids is allowed (e.g. chronic obstructive pulmonary disease, anti-emetic) ;
- •low doses of corticosteroids for brain metastasis treatment is allowed
- •9. Patients with symptomatic visceral disease in need of urgent disease control
- •10. Symptomatic brain or other CNS metastases.
- •Previously treated symptomatic brain metastases are allowed provided the patient is free of symptoms, prior radiotherapy for brain metastasis was more than four weeks before enrollment and the dose of corticosteroids is low and stable for at least two weeks prior to enrollment
- •Other protocol defined exclusion criteria may apply
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