ISRCTN43286545已完成3 期
A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for post-menopausal women with hormone-receptor positive, node positive early stage breast cancer
European Institute of Oncology (IEO) (Italy)0 个研究点目标入组 4,884 人开始时间: 2009年11月3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
- 4,884
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29158011 results (added 10/09/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Patients must be post-menopausal; definitive confirmation of post-menopausal status is required
- •2. Patients must be accessible for follow-up
- •3. At diagnosis, patients must have had operable, non-inflammatory breast cancer
- •4. Patients must be clinically disease-free at randomisation
- •5. Patients must have had steroid hormone receptor positive tumours (oestrogen receptor [ER] and/or progesterone receptor [PgR]), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy
- •6. Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes
- •7. There must have been no evidence of recurrent disease or distant metastatic disease at any time prior to randomisation
- •8. Patients must have had proper local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease
- •9. Patients must have clinically adequate hepatic function
- •10. Patients must have completed 4 to 6 years of prior adjuvant endocrine therapy with SERMs, AI or a sequential combination of both. When calculating 4 - 6 years, neoadjuvant endocrine therapy should not be included.
- •11. Patients must have stopped prior endocrine SERM/AI therapy, and must be randomized within 12 months (1 year) of the last dose of prior endocrine SERM/AI therapy
- •12. Patients may have received any type of prior adjuvant therapy, including but not limited to neoadjuvant chemotherapy, neoadjuvant endocrine therapy, adjuvant chemotherapy, trastuzumab, ovarian ablation, GnRH analogues, lapatinib
- •13. Patients must have stopped hormone replacement therapy (HRT), bisphosphonates (except for treatment of bone loss), or any investigational agent at randomisation
- •14. Pathology material from the primary tumour must be available for submission for central review as part of the quality control measures for this protocol
- •15. Written informed consent (IC) must be signed and dated by the patient and the investigator prior to randomisation
- •16. Written consent to pathology material submission, indicating the patient has been informed of and agrees to tissue material use, transfer and handling, must be signed and dated by the patient and the investigator prior to randomisation
- •17. Females, no defined age limits
排除标准
- •1. Patients who have had bilateral breast cancer
- •2. Patients who have had a bone fracture due to osteoporosis at any time during the 4-6 years of prior endocrine SERM/AI therapy
- •3. Patients who have had any previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma
- •4. Patients who have had any other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up
- •5. Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements
研究者
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