ISRCTN66949472已完成3 期
The role of ovarian function suppression (OFS) in premenopausal women with hormone responsive early breast cancer: tamoxifen versus exemestane - a multicentre randomised interventional trial
International Breast Cancer Study Group (IBCSG)0 个研究点目标入组 2,672 人开始时间: 2010年6月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,672
研究概览
简要总结
2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24881463 results (added 09/09/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Pre-menopausal women (oestradiol [E2] levels in the premenopausal range), aged above 18 years
- •2. Histologically proven, resected breast cancer. Pathology material should be available for submission for central review.
- •3. Hormone receptor positive (HR+) tumour. HR must be determined using immunohistochemistry (IHC): oestrogen receptor (ER) and/or progesterone receptor (PgR) greater than or equal to 10%.
- •4. Tumour confined to the breast and axillary nodes without detected metastases elsewhere with the exception of tumour detected in the internal mammary chain nodes by sentinel node procedure
- •5. Proper surgery (total mastectomy or breast conserving procedure plus radiation) for primary disease with no known clinical residual disease
- •6. Axillary lymph node dissection or negative axillary sentinel node biopsy
- •7. Written informed consent and accessible for follow-up
- •8. Patients must be informed of and agree to data and tissue transfer and handling, in accordance with national data protection guidelines
排除标准
- •1. Postmenopausal
- •2. Distant metastatic disease
- •3. Locally advanced inoperable breast cancer
- •4. Bilateral invasive breast cancer
- •5. Positive final margins
- •6. Clinically detectable residual axillary disease
- •7. History of previous ipsilateral or contralateral invasive breast cancer
- •8. Previous or concomitant malignancy except adequately treated basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or bladder, contralateral or ipsilateral in-situ breast cancer
- •9. Other non-malignant systemic diseases that would prevent prolonged follow-up
- •10. Patients who have had a bilateral oophorectomy or ovarian irradiation
- •11. History of noncompliance to medical regimens or considered potentially unreliable
- •12. Previous or concomitant malignancy except adequately treated basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or bladder, contralateral or ipsilateral in-situ breast cancer
- •13. Other non-malignant systemic diseases that would prevent prolonged follow-up
研究者
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