PER-062-06已完成未知
Phase III Randomized Trial of Exemestane vs Anastrozole in Postmenopausal Women with Primary Breast Cancer with Positive Receptors
INTERNATIONAL BREAST CANCER STUDY GROUP - IBCSG,0 个研究点目标入组 0 人开始时间: 2006年10月25日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 0 至 0（—）
入选标准
- •1) Patients with histologically proven invasive breast cancer, resected in the following TNM categories: pT1, pT2 or pT3; pNx, pN0, pN1, pN2 or, only when the only basis for this classification is the presence of 10 axillary nodes or more, pN3; M0. Surgical margins should be free of invasive carcinoma and DCIS.
- •2) The primary tumor must be a positive receptor.
- •3) Postmenopausal condition prior to chemotherapy.
- •4) Patients with bilateral breast cancers will be eligible only if their cancers are synchronous.
- •5) Patients must have had a bilateral mammogram within 12 months before randomization.
- •6) Radiological investigations must be negative for metastasis.
- •7) Patients should be randomized in a minimum of 3 weeks and a maximum of 3 months after the end of chemotherapy. If no chemotherapy is given, patients should be recruited at a minimum of 3 weeks and no more than 3 months after the first surgery.
- •8) Minimum life expectancy of 5 years.
- •9) Hematology: Leukocytes> 3.0 x 10-9 / L or granulocytes (polymorphs + juveniles)> 1.5 x 10-9 / L; platelets> 100 x 10-9 / L within 4 weeks before randomization.
- •10) Biochemistry: AST (SGOT) and / or ALT (SGPT) and alkaline phosphatase <2 x at the upper institutional normal limit (UNL).
- •11) Performance status ECOG 0, 1, or 2.
- •12) The patient should be able to swallow the study medication and have adequate swallowing to maintain a reasonable state of nutrition.
- •13) Patients must be eligible for treatment and follow-up. Researchers should ensure that randomized patients in this study will be available for complete documentation of treatment, toxicity and follow-up.
- •14) The consent of the patient must be obtained according to the Institutional requirements and / or the Ethics Committees.
- •15) The treatment of the study should begin within 10 working days after the randomization.
排除标准
- •1) Patients with histologically proven invasive breast cancer, resected in the following TNM categories: pT1, pT2 or pT3; pNx, pN0, pN1, pN2 or, only when the only basis for this classification is the presence of 10 axillary nodes or more, pN3; M0. Surgical margins should be free of invasive carcinoma and DCIS.
- •2) The primary tumor must be a positive receptor.
- •3) Postmenopausal condition prior to chemotherapy.
- •4) Patients with bilateral breast cancers will be eligible only if their cancers are synchronous.
- •5) Patients must have had a bilateral mammogram within 12 months before randomization.
- •6) Radiological investigations must be negative for metastasis.
- •7) Patients should be randomized in a minimum of 3 weeks and a maximum of 3 months after the end of chemotherapy. If no chemotherapy is given, patients should be recruited at a minimum of 3 weeks and no more than 3 months after the first surgery.
- •8) Minimum life expectancy of 5 years.
- •9) Hematology: Leukocytes> 3.0 x 10-9 / L or granulocytes (polymorphs + juveniles)> 1.5 x 10-9 / L; platelets> 100 x 10-9 / L within 4 weeks before randomization.
- •10) Biochemistry: AST (SGOT) and / or ALT (SGPT) and alkaline phosphatase <2 x at the upper limit of the institutional normal (UNL).
- •11) Performance status ECOG 0, 1, or 2.
- •12) The patient should be able to swallow the study medication and have adequate swallowing to maintain a reasonable state of nutrition.
- •13) Patients must be eligible for treatment and follow-up. Researchers should ensure that randomized patients in this study will be available for complete documentation of treatment, toxicity and follow-up.
- •14) The consent of the patient must be obtained according to the Institutional requirements and / or the Ethics Committees.
- •15) The treatment of the study should begin within 10 working days after the randomization.
研究者
相似试验
进行中（未招募）
1 期
A randomized phase III trial of exemestane versus anastrozole in postmenopausal women with receptor positive primary breast cancer - MA.27Post-menopausal women, histologically or cytologically confirmed, receptor-positive,adequately excised, primary breast cancerEUCTR2005-001893-28-HUInternational Breast Cancer Study Group (IBCSG)7,576
进行中（未招募）
1 期
A randomized phase III trial of exemestane versus anastrozole in postmenopausal women with receptor positive primary breast cancer - MA.27EUCTR2005-001893-28-BEInternational Breast Cancer Study Group (IBCSG)5,800
已完成
3 期
IBCSG 30-04 / NCIC CTG MA.27Receptor positive primary breast cancerCancer - BreastACTRN12605000389606Australia and New Zealand Breast Cancer Trials Group Ltd5,800
已完成
3 期
Phase III Randomized Adjuvant Study of Exemestane Versus Anastrozole Versus Tamoxifen in Hormone-Responsive Postmenopausal Breast Cancer PatientsJPRN-C000000057-SAS BC 04 executive committee300
进行中（未招募）
不适用
Tamoxifen and Exemestane Trial (TEXT)Premenopausal women with histologically proven, resected breast cancer with ERand/or PgR positive tumorsMedDRA version: 14.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2004-000168-28-SEInternational Breast Cancer Study Group (IBCSG)2,639