NCT00002777已完成3 期
RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS
European Organisation for Research and Treatment of Cancer - EORTC96 个研究点 分布在 12 个国家目标入组 342 人开始时间: 1996年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 96
研究概览
简要总结
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of exemestane vs tamoxifen, in terms of progression-free survival, in postmenopausal women with locally recurrent or metastatic breast cancer.
- Determine the safety profile of exemestane in these patients.
- Compare the overall survival of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. (Phase II of this study closed as of 6/14/00). Patients are stratified by participating center, prior adjuvant tamoxifen (yes vs no), prior chemotherapy for metastatic disease (yes vs no), and dominant site of metastasis (visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only).
Patients are randomized to receive either oral exemestane or oral tamoxifen daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 18 months and then at least every 6 months thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically proven adenocarcinoma of the breast that is metastatic and progressive or locally recurrent and inoperable
- •At least one bidimensionally measurable or evaluable lesion
- •Lytic bone lesions on x-ray/CT scan, surrounded by calcified bone, and at least 1 cm
- •Bidimensionally measurable extraosseous disease required for patients on bisphosphonates
- •The following are not considered evaluable:
- •Previously irradiated lesions
- •Lymphangitic spread
- •Blastic bone lesions
- •Pleural effusions
- •No rapidly progressive disease for which hormonal therapy is not indicated
- •No massive visceral disease (i.e., more than one third of any organ)
- •No brain metastases
- •Hormone receptor status:
- •Estrogen receptor positive or progesterone receptor positive, defined by 1 of the following:
- •At least 10 femtomoles H3-estrogen or at least 20 femtomoles
- •H3 progesterone binding per mg of cytosol protein by DCC or sucrose density method
- •At least 0.10 femtomoles H3-estrogen or at least 0.20 femtomoles
- •H3-progesterone binding per mg of DNA by IF/EIA technique
- •Positive immunohistochemistry noted on pathology report
- •Unknown receptor status eligible provided:
- •Disease-free interval of at least 2 years since adjuvant therapy or initial surgery (if no adjuvant therapy), including most recently treated tumor in bilateral breast cancer if status unknown in one primary tumor
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status:
- •Postmenopausal by 1 of the following:
- •Natural menopause and more than 1 year since last menstrual period (LMP)
- •Radiation-induced oophorectomy and more than 1 year since LMP
- •Chemotherapy induced menopause if:
- •At least 1 year since LMP (+ 1 year post-tamoxifen)
- •Serum FSH and LH and plasma estradiol levels in postmenopausal range
- •LHRH-induced amenorrhea
- •Surgical castration
- •Patients under age 56 with prior hysterectomy and 1 or both ovaries intact or tamoxifen-induced amenorrhea with at least 12 months since prior tamoxifen must have postmenopausal serum FSH and LH and plasma estradiol concentrations
- •Performance status:
- •ECOG (WHO) 0-2
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT/SGPT less than 2.5 times ULN (less than 5 times ULN with liver metastases)
- •Creatinine less than 1.5 times ULN
- •Cardiovascular:
- •No deep venous thrombosis
- •No mental incapacitation
- •No severe concurrent disease
- •No prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- 另有 17 项未显示
排除标准
- 未提供
研究者
研究点 (96)
Loading locations...
相似试验
已完成
2 期
Exemestane Plus Goserelin in Treating Premenopausal Women With Metastatic Breast CancerBreast CancerNCT00010010NYU Langone Health
已完成
3 期
Exemestane or Anastrozole in Treating Postmenopausal Women Who Have Undergone Surgery for Primary Breast CancerBreast CancerNCT00066573NCIC Clinical Trials Group7,576
已完成
3 期
Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of TamoxifenBreast CancerNCT00016432NSABP Foundation Inc1,598
Unknown
3 期
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast CancerBreast CancerNCT00003418International Collaborative Cancer Group4,400
已完成
3 期
Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast CancerBreast CancerNCT00066703ETOP IBCSG Partners Foundation2,672