EUCTR2005-003434-18-BE进行中（未招募）不适用
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” - Chemotherapy Adjuvant Study for women at advanced Age (CASA)
International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 1,296 人开始时间: 2007年1月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Patient Characteristics:
- •- 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.
- •Disease Characteristics:
- •- 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 and other criteria in 3.2 and 3.3 are met.
- •Prior Surgery:
- •- 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).
- •Prior Treatment:
- •- 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.
- •Concurrent Treatment (at the time of randomization patients should not be
- •receiving these treatments):
- •- No hormone replacement therapy (HRT).
- •- 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.
- •Organ function at the time of randomization (within 2 months before
- •randomization):
- •- Adequate bone marrow, renal, and hepatic function must be assessed within 2 months before randomization and values must meet the following criteria:
- •WBC = 3.0 G/L
- •Granulocyte count = 1.500 G/L
- •Platelet count = 100 G/L
- •Serum creatinine < 120 µmol/L (< 1.35 mg/dl)
- •Calculated creatinine clearance at least 50 mL/min
- •Serum bilirubin within normal/reference range
- •AST/ALT within 1.5 x upper normal limit
- •- Adequate cardiovascular function defined as the following must be assessed within 2 months before randomization:
- •LVEF = 50% by echocardiography, radionuclide ventriculography or Multigated
- •Angiography (MUGA)
- •No ECG evidence of acute ischemia
- •No evidence of medically relevant conduction system abnormalities, which in the
- •opinion of the investigator would preclude trial entry
- •No myocardial infarction within the past 6 months
- •No New York Heart Association (NYHA) class III or IV congestive heart failure
- •Protocol Requirements BEFORE Randomization:
- •- Written Informed Consent (IC) must be signed and dated by the patient and the
- •investigator prior to completing QL Forms and prior to randomization.
- •- Patients must have completed the baseline QL assessment, including the patient-rated Quality of Life Quetionnaire Form QL as well as the two physician-documented tests for cognitive (Mini-Cog test) and physical (Vulnerable Elders Survey [VES-13] test) functioning and the Assessment Checklist. The only exceptions are physical impair
排除标准
- •Disease Characteristics:
- •- Patients with locally advanced inoperable breast cancer including inflammatory breast cancer, supraclavicular node involvement, or enlarged internal mammary nodes (unless pathologically negative).
- •Prior/Concurrent Disease:
- •- 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 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.
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