NL-OMON31071撤回3 期
Chemotherapy Adjuvant Study for women at advanced Age (CASA); 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* - CASA
International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 35 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Women aged 66 years or older with histologically proven, resected breast cancer.
- •- Patients must not be candidates for endocrine therapy or standard chemotherapy regimen.
- •- Performance status (ECOG) 0-2.
- •- Patients must have endocrine nonresponsive tumors. (The recommended definition of endocrine nonresponsive: ER less than 10% of cells stained positive by immunohistochemical evaluation. If PgR is done, it should also be less than 10% of cells stained positive by immunohistochemical evaluation.)
- •- The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere.
- •- Patients with synchronous (diagnosed histologically within 2 months) bilateral invasive breast cancer are eligible if all tumors are endocrine nonresponsive.
- •- Patients must have had surgery for primary breast cancer (with or without axillary
- •clearance) with no known clinical residual loco-regional disease.
- •- Margins must be negative for invasive breast cancer and DCIS.
- •- Patients should be randomized and start treatment as close to definitive surgery as possible; within 6 weeks is recommended and not more than 16 weeks (from last surgery in case of bilateral breast cancer).
- •- Adequate bone marrow, renal, and hepatic function
- •- Adequate cardiovascular function
排除标准
- •- Patients with locally advanced inoperable breast cancer including inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary
- •nodes (unless pathologically negative).
- •- Patients with a history of any prior ipsilateral or contralateral invasive breast
- •- Patients with previous or concomitant malignancy diagnosed within the past
- •five years. Patients with adequately treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma are eligible regardless of the date of diagnosis.
- •- Patients with other non-malignant uncontrolled systemic diseases that would
- •preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV.
- •- Patients with myocardial infarction, pulmonary embolism or deep venous thrombosis within 6 months prior to randomization.
- •- Patients with significant malabsorption syndrome or disease affecting gastrointestinal tract function.
- •- Patients with at least one of the so-called *geriatric syndromes*: dementia,
- •delirium, major depression (as diagnosed by a psychiatrist), recent falls, spontaneous bone fractures, neglect, and abuse.
- •- No hormone replacement therapy (HRT).
- •- No prior neoadjuvant or adjuvant therapy for breast cancer. Note: Radiotherapy is allowed prior to randomization.
- •- Raloxifene, tamoxifen, or other SERM must be discontinued at least 4 weeks before
- •randomization.
- •- No hormonal therapy, except steroids for adrenal failure, hormones for non-breast cancer related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic.
- •- No treatment with bisphosphonates, except for the treatment of osteoporosis
研究者
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