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临床试验/EUCTR2006-004018-42-IT
EUCTR2006-004018-42-IT进行中(未招募)不适用

A phase III study comparing anastrozole, letrozole and exemestane, upfront (for 5 years) or sequentially (for 3 years after 2 years of tamoxifen), as adjuvant treatment of postmenopausal patients with endocrine-responsive breast cancer - GIM3- FATA

IVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II0 个研究点开始时间: 2007年5月15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

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

  • -Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N -Postmenopausal status -Primary tumor positive for ER or PgR (10% tumor cells positive by immunoistochemistry or  10 fmol/mg cytosol protein by ligand binding assay) -Patients with HER-2 positive tumors are eligible provided that they receive trastuzumab according to registered schedule. -Signed informed consent
  • 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

  • - HRT concurrent or assumed during the month before randomization - Recurrent or metastatic disease - HER-2 positive tumors if treatment with trastuzumab is not feasible - Concurrent illness that contraindicate adjuvant endocrine treatment - Patients who have received TAM as part of any breast cancer prevention trial - Previuos history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied - Concomitant severe disease which would place the patient at unusual risk - Concurrent treatment with other experimental drugs - Patients treated with systemic investigational drugs within the past 30 days

研究者

发起方
IVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II

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