EUCTR2005-001893-28-HU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.27
International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 7,576 人开始时间: 2005年10月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7,576
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
- •Patients must have completely resected and histologically confirmed invasive breast cancer in the following TNM categories (AJCC Version 6): pT1, pT2 or pT3; pNx, pN0, pN1, pN2 or, only when the sole basis for this classification is the presence of 10 or more involved axillary nodes, pN3; M0. Surgical margins must be clear of invasive carcinoma and DCIS/LCIS. Patients with positive sentinel node biopsies must have subsequent axillary dissection to be eligible; negative sentinel node biopsies require no more axillary surgery for eligibility.
- •The primary tumour must be receptor-positive i.e. ER and/or PgR positive (defined as a tumour receptor content of > 10 fmol/mg protein, or receptor positive by immunohistochemistry: ERICA or PgRICA)
- •Postmenopausal status, prior to chemotherapy
- •Patients with bilateral breast cancers are eligible only if their cancers are synchronous (diagnosed at the same time). One or both tumours need to have receptor positive markers. One could be negative.
- •Patients must have had a bilateral mammogram within 12 months prior to randomization, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required.
- •Radiologic investigations (bone scan, abdominal ultrasound or CT abdomen, chest x-ray) must be negative for metastases
- •Patients must be randomized a minimum of 3 weeks and a maximum of 3 months after completion of chemotherapy. If no chemotherapy is given, patients must be enrolled no less than 3 weeks and no later than 3 months after primary surgery.
- •Minimum life expectancy of 5 years.
- •Hematology: WBC > 3.0 x 109/L or granulocytes (polymorphs + bands) > 1.5 x 109/L; platelets > 100 x 109/L within 4 weeks prior to randomization.
- •Biochemistry: AST (SGOT) and/or ALT (SGPT) and alkaline phosphatase< 2 x the upper limit of institutional normal (UNL) unless imaging examinations have ruled out metastatic disease. Creatinine < 1.5 X UNL within 4 weeks prior to randomization.
- •ECOG Performance Status 0, 1, or 2
- •Patient must be able to swallow study medication and have adequate unassisted oral intake to maintain a reasonable state of nutrition.
- •Patients must be accessible for treatment and follow-up.
- •Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
- •Protocol therapy must begin within 10 working days of randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Premenopausal status (premenopausal women excluded because aromatase inhibitors are not employed in this group as monotherapy).
- •Patients with only receptor negative primary tumours.
- •Patients with metachronous breast cancer (breast cancers diagnosed at different times).
- •Less than 3 weeks or more than 3 months have elapsed since completion of chemotherapy; if no chemotherapy, less than 3 weeks or more than 3 months have elapsed since primary surgery.
- •Patients with locally recurrent or metastatic breast cancer
- •Patients with a history of other (non-breast) malignancies, except: adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years.
- •Patients receiving concurrent hormonal therapy with estrogens, progesterones or androgens, or any selective estrogen receptor modulator (SERM). Vaginal atrophy refractory to local measures may be treated, at the discretion of the investigator, with intermittent vaginal estrogens.
- •Patients having received prior treatment with a recognized aromatase inhibitor.
- •Any co-existing medical or psychiatric condition that is likely to interfere with study procedures and/or results.
- •Prior treatment on a trial for breast cancer if permission has not been obtained from the sponsors of the original study for the patient to participate in MA.27. (MA.20 patients may participate in MA.27. MA.21 patients may not participate in MA.27.)
- •Any prior treatment with tamoxifen or SERMs other than raloxifene. (Previous use of raloxifene is permitted, but the patient must have been off raloxifene for 3 weeks prior to randomization.) Any prior treatment with hormones or steroids (including over-the-counter products and supplements considered to have an estrogenic effect if not discontinued at least 3weeks prior to randomization
- •Patients with a prior diagnosis of in situ carcinoma in the contralateral breast treated with partial mastectomy and/or hormonal therapy
研究者
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