EUCTR2007-003877-21-GB进行中（未招募）不适用
Trial of Perioperative Endocrine Therapy - Individualising Care (POETIC) - POETIC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Hormone receptor positive breast cancer is defined as an Allred score of 3 or more, or a Histoscore of 2 or more, or more than 1% of positive cells for oestrogen receptor or progesterone receptor.
- •1) Post menopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman aged =50 years fulfilling any one of the following criteria:
- •i) aged >50 years with amenorrhoea >12 months and an intact uterus;
- •ii) has undergone a bilateral oophorectomy;
- •iii) in women who have undergone a hysterectomy, then FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged <55 years; or
- •iv) in women who have been on HRT within the last 12 months and therefore not amenorrhoeic, FSH levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged <55 years.
- •2) No evidence of metastatic spread by standard assessment according to local guidelines
- •3) Standard adjuvant endocrine therapy indicated
- •4) A palpable tumour of any size , or a tumour with an ultrasound size of at least 1.5cm
- •5) WHO performance status of 0, 1, or 2
- •6) Written informed consent to participate in the trial and to donation of tissue (fresh tissue and surplus tissue from diagnostic procedures) and blood samples.
- •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 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •1) Locally advanced/inoperable breast cancer
- •2) Evidence of metastatic disease
- •3) Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS allowed)
- •4) Concurrent use (defined as use within 4 weeks prior to baseline tissue sample being taken prior to entry) of HRT or any other oestrogen-containing medication (including vaginal oestrogens)
- •5) Previous use of oestrogen implants at ANY time
- •6) Prior endocrine therapy or chemotherapy for breast cancer
- •7) Any invasive malignancy diagnosed within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
- •8) Any severe co-incident medical disease, inability to give informed consent or unavailability for follow-up
- •9) Treatment with an unlicensed or investigational drug within 4 weeks before randomisation
- •10) Continuous long term systemic steroid usage
研究者
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