ISRCTN41579286进行中（未招募）未知
Post-operative avoidance of radiotherapy: biomarker selection of women categorised to be in a very low risk group by IHC4+C
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
研究概览
简要总结
2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34127033/ (added 13/08/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Provision of written informed consent to participate in the PRIMETIME study
- •2. Provision of slides for research testing and availability of KI67 result (contact ICR-CTSU to confirm)
- •3. Women aged =60 years (younger patients are eligible if they are post-menopausal and have co-morbidities that imply a high risk of radiotherapy toxicity e.g. significant cardiovascular disease with left sided breast cancer)
- •4. Women having had breast conserving surgery with complete resection of tumour tissue (=1 mm microscopic, circumferential margins of normal tissue from invasive cancer and DCIS)
- •5. AJCC staging of pT1/pN0/M0 (DCIS is allowed in combination with invasive breast cancer; isolated tumour cells in axillary nodes are allowed)
- •6. Histological confirmation of grade 1 or 2 invasive breast cancer
- •7. Oestrogen receptor (ER) positive according to local practice. The H score must be available.
- •8. Progesterone receptor (PR) positive according to local practice. The percentage positivity must be available.
- •9. Human epidermal growth factor receptor (HER2) negative according to local practice
- •10. Patients must be recommended for =5 years adjuvant endocrine therapy according to local policy and in the investigator’s opinion, deemed able to comply with the duration of treatment
排除标准
- •1. Patients known to have lymphovascular space invasion and/or axillary nodal micrometastases or macrometastases.
- •2. Patients with a past history of malignancy excep:
- •2.1. Basal cell skin cancer and CIN cervix uteri
- •2.2.Treated, localised squamous cell carcinoma of the skin
- •2.3. Malignancies treated with curative intent and the patient has been disease free =5 years
- •3. Patients who have had an ipsilateral mastectomy
- •4. Patients who have received neoadjuvant therapy (endocrine or cytotoxic chemotherapy with therapeutic intent) or who are deemed by the MDT to require adjuvant cytotoxic chemotherapy
- •5. Patients with mammographically occult breast cancers, ie. present with lump, but not visible on mammogram
研究者
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