EUCTR2005-005721-55-GB进行中（未招募）不适用
Adjuvant Cytotoxic Chemotherapy in Older Women - ACTIO
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- All
入选标准
- •Age 70 years or over of either sex;
- •Performance status 0 or 1;
- •Histological diagnosis of invasive breast carcinoma;
- •Primary operable breast cancer surgically treated by wide local excision or mastectomy with clear margins (>1mm apart from deep margin if full thickness resection).
- •Axillary staging performed by sentinel node biopsy, axillary sampling or clearance. All nodepositive patients must have had axillary clearance or radiotherapy to the axilla (see appendix 2);
- •High risk of relapse (approx 30%). This will include any patient with HER2 positive disease, or ER negative disease. High risk ER positive disease would typically be expected to be grade 3 with 4+ positive nodes. Other ER positive patients may be considered on a individual basis
- •Early stage disease with no evidence of metastases clinically or on routine staging investigations;
- •High risk of relapse within 5 years (risk factors evaluated at clinicians discretion)
- •Fit to receive any of the trial chemotherapy regimens, with adequate bone marrow, hepatic, and renal function i.e.
- •Hb > 9g/dL; WBC > 3 ? 109/L; platelets > 100 x 109/L;
- •Bilirubin within normal range (unless known Gilbert’s disease);
- •AST/ALT = 1.5 x Upper limit of normal (ULN);
- •Albumen within normal range;
- •Creatinine = 1.5 x ULN and calculated creatinine clearance using Cockroft-Gault formula > 50 ml/min; and
- •No active, uncontrolled infection;
- •Written informed consent given;
- •No previous anthracycline chemotherapy at any time, and no other systemic anti cancer therapy within the last 5 years, unless exposure to treatment is brief, and in the context of a peri-operative trial with biological endpoints.
- •No previous mantle radiotherapy
- •Randomisation as soon as reasonably possible after definitive surgery, ideally within 8 weeks and
- •Patient available for routine long term hospital follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •Previous invasive breast cancer within the last 5 years;
- •Previous DCIS within the last 5 years if treated systemically;
- •Any previous haematological malignancy or melanoma;
- •Any previous solid tumours within the last 5 years;
- •Primary inoperable breast cancer (T4 and/or N3 disease);
- •Patients who have had breast conserving surgery in whom there is a contra-indication for, or decline of, post-operative radiotherapy;
- •Patients with significant cardiac disease as determined by MUGA or ECHO (LVEF < 55% excluded) or
- •Patients not able or willing to give informed consent.
研究者
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