ACTRN12606000077561已完成3 期
Phase III Trial Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®, Doxil®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a Standard Chemotherapy Regimen.
Australian New Zealand Breast Cancer Trials Group0 个研究点目标入组 1,296 人开始时间: 2006年2月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,296
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 66 Years 至 ot stated（—）
- 性别
- Female
入选标准
- •Histologically proven, hormone receptor negative, completely resected breast cancer confined to the breast and axillary nodes without detected metastases elsewhere; patients must not be candidates for endocrine therapy or standard chemotherapy regimen; margins must be negative for invasive breast cancer and DCIS; adequate bone marrow, renal, and hepatic function; adequate cardiovascular function and geographically accessible for follow-up.
排除标准
- •Patients with locally advanced inoperable breast cancer; patients with a history of any prior ipsilateral or contralateral invasive breast cancer; patients with previous or concomitant malignancy diagnosed within the past five years; patients with other non-malignant uncontrolled systemic diseases; patients with myocardial infarction, pulmonary embolism or deep venous thrombosis within 6 months prior to randomisation; patients with significant malabsorption syndrome or disease affecting gastrointestinal tract function; prior neoadjuvant or adjuvant therapy for breast cancer; hormone replacement therapy (HRT); hormonal therapy, except steroids for adrenal failure, hormones for non-breast cancer related conditions; treatment with bisphosphonates, except for the treatment of osteoporosis.
研究者
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Phase III Trials Evaluating the Role of Adjuvant Pegylated Liposomal Doxorubicin (PLD, Caelyx®, Doxil®) for Women (age 66 years or older) with Endocrine Nonresponsive Breast Cancer Who Are NOT Suitable for Being Offered a Standard Chemotherapy Regimen” - Chemotherapy Adjuvant Study for women at advanced Age (CASA)Older women (66 years of age or older) with histologically proven, resected breast cancer. The disease must be classified as endocrine nonresponsive and patients must not be candidates for endocrine therapy or for an adjuvant chemotherapy program which includes a standard” anthracycline-containing chemotherapy regimen.EUCTR2005-003434-18-HUInternational Breast Cancer Study Group (IBCSG)1,296
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