Trial of PeriOperative Endocrine Therapy - Individualising Care

Institute of Cancer Research (UK)0 个研究点目标入组 4,000 人开始时间: 2007年12月18日最近更新: 2021年4月12日

适应症

试验速览

•1. Postmenopausal women with core biopsy-proven hormone receptor positive invasive breast cancer. Postmenopausal is defined as a woman fulfilling any one of the following criteria:
•1.1. Aged greater than 50 years with amenorrhoea greater than 12 months and an intact uterus
•1.2. Has undergone a bilateral oophorectomy
•1.3. In women who have undergone a hysterectomy, then Follicle Stimulating Hormone (FSH) levels within the postmenopausal range (utilising ranges from the testing laboratory facility) are required if the patient is aged less than 55 years
•1.4. In women who have been on Hormone Replacement Therapy (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 less than 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 minimum size, or a tumour with an ultrasound size of at least 1.5 cm
•5. World Health Organization (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)

•Current exclusion criteria as of 11/10/2012:
•1. Locally advanced/inoperable breast cancer
•2. Evidence of metastatic disease
•3. Concurrent use of HRT
•4. Prior endocrine therapy for breast cancer
•5. Neoadjuvant chemotherapy
•6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
•7. Any severe coincident medical disease or inability to give informed consent
•8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation
•9. Previous invasive breast cancer or bilateral breast cancer (surgically treated DCIS or LCIS allowed)
•10. Previous use of oestrogen implants at ANY time
•11. Continuous long term systemic steroid usage
•Previous exclusion criteria until 11/10/2012:
•1. Locally advanced/inoperable breast cancer
•2. Evidence of metastatic disease
•3. Concurrent use of HRT
•4. Prior endocrine therapy for breast cancer
•5. Neoadjuvant chemotherapy
•6. Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ)
•7. Any severe coincident medical disease or inability to give informed consent
•8. Treatment with a non-approved or investigational drug within 4 weeks before randomisation

发起方

Institute of Cancer Research (UK)