ISRCTN11896599进行中（未招募）未知
Randomised controlled trial evaluating effectiveness of neoadjuvant endocrine treatment in post-menopausal women
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 1,440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 02/06/2023:
- •Main study:
- •2. Clinically post-menopausal; including one of:
- •2.1. Amenorrhoea >12 months and an intact uterus
- •2.2. Bilateral oophorectomy
- •2.3. For those with a history of hysterectomy, or hormone replacement therapy (HRT) within 12 months, venous FSH levels classified as post-menopausal by the testing laboratory if any doubt
- •3. Unifocal, newly diagnosed breast cancer visible on USS
- •4. Strongly ER+; defined as Allred scores of 7 or 8 or equivalent*
- •5. HER2- by immunohistochemistry, or 2+ and not amplified by in situ hybridisation
- •6. T-stage 1, 2 or 3 (=15 mm)
- •7. Axillary N0-1 on diagnostic USS +/- negative fine-needle aspiration (FNA) or core biopsy
- •8. Suitable for surgery and radiotherapy
- •9. Chemotherapy unlikely to be indicated
- •10. Participant is able and willing to give informed consent for participation in the trial
- •11. In the Investigator's opinion, is able to comply with all trial requirements
- •* or equivalent may include a histochemical score (H-score) = 200.
- •QRI (information study)
- •1. Patients approached for participation in the EndoNET study
- •2. Patient inclusions are the same as for the EndoNET study
- •Healthcare professionals (HCPs) and research personnel (RPs):
- •1. HCPs or RPs involved in management, operation or recruitment for the EndoNET study
- •2. Trial management group (TMG) members with a role in planning/coordinating recruitment
- •Previous inclusion criteria:
- •Main study:
- •2. Clinically post-menopausal; including one of:
- •2.1. Amenorrhoea >12 months and an intact uterus
- •2.2. Bilateral oophorectomy
- •2.3. For those with a history of hysterectomy, or hormone replacement therapy (HRT) within 12 months, venous FSH levels classified as post-menopausal by the testing laboratory if any doubt
- •3. Unifocal, newly diagnosed breast cancer visible on USS
- •4. Strongly ER+; defined as Allred scores of 7 or 8 or equivalent
- •5. HER2- by immunohistochemistry, or 2+ and not amplified by in situ hybridisation
- •6. T-stage 2 or 3 (>2 cm)
- •7. Axillary N0-1 on diagnostic USS +/- negative fine-needle aspiration (FNA) or core biopsy
- •8. Suitable for surgery and radiotherapy
- •9. Chemotherapy unlikely to be indicated
- •10. Participant is able and willing to give informed consent for participation in the trial
- •11. In the Investigator's opinion, is able to comply with all trial requirements
- •QRI (information study)
- •1. Patients approached for participation in the EndoNET study
- •2. Patient inclusions are the same as for the EndoNET study
- •Healthcare professionals (HCPs) and research personnel (RPs):
- •1. HCPs or RPs involved in management, operation or recruitment for the EndoNET study
- •2. Trial management group (TMG) members with a role in planning/coordinating recruitment
排除标准
- •Main study:
- •The participant may not enter the trial if ANY of the following apply:
- •1. Bilateral breast cancer
- •2. ER- or HER2+
- •3. Stage IV disease (distant metastasis)
- •4. Previous neoadjuvant treatment for breast cancer
- •5. Previous invasive malignancy within 5 years other than basal cell carcinoma
- •6. Concurrent use (at the time of randomisation) of HRT or any other oestrogen-containing medication (including vaginal oestrogens)
- •7. Ovarian suppression/ablation for the purposes of trial entry not permitted
- •QRI (information study):
- •1. Patient exclusions are the same as for the EndoNET study
- •2. Patient does not wish to have consultations recorded and/or participate in interview
- •HCPs and RPs:
- •1. HCPs or RPs who do not wish to have consultations recorded and/or participate in interview
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