A multicentre randomised interventional trial on the benefits of ovarian function suppression in pre-menopausal women with oestrogen receptor positive breast cancer

European Institute of Oncology (IEO) (Italy)0 个研究点目标入组 3,066 人开始时间: 2010年5月12日最近更新: 2024年6月3日

适应症

试验速览

2013 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/24095609 protocol (added 28/02/2019) 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28911092 results (added 28/02/2019) 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/26092816 results (added 28/02/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27044936 results (added 28/02/2019) 2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24881463 results (added 28/02/2019) 2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27022111 results (added 28/02/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29863451 results (added 28/02/2019) 2015 Results article in https://www.ncbi.nlm.nih.gov/pubmed/25495490 results (added 28/02/2019)

•1. Pre-menopausal women (estradiol [E2] levels in the pre-menopausal range) either after chemotherapy or without chemotherapy
•2. Randomisation within an 8-month evaluation period after end of CT, or within 12 weeks after definitive surgery for patients with no CT. Patients with temporary chemotherapy-induced amenorrhoea who regain pre-menopausal status within 6 months of the final chemotherapy dose are eligible.
•3. Histologically proven, resected breast cancer. Pathology material available for submission for central review.
•4. Hormone receptor (HR) positive tumour. HR must be determined using immunohistochemistry (IHC): ER and/or progesterone receptor (PgR) greater than or equal to 10%
•5. Tumour confined to the breast and axillary nodes without detected metastases elsewhere with the exception of tumour detected in the internal mammary chain nodes by sentinel node procedure
•6. Proper surgery (total mastectomy or breast conserving procedure plus radiation) for primary disease with no known clinical residual disease
•7. Axillary lymph node dissection or negative axillary sent

•1. Post-menopausal
•2. Distant metastatic disease
•3. Locally advanced inoperable breast cancer
•4. Bilateral invasive breast cancer
•5. Positive final margins
•6. Clinically detectable residual axillary disease
•7. History of previous ipsilateral or contralateral invasive breast cancer
•8. Previous or concomitant malignancy except adequately treated basal/squamous cell carcinoma of the skin, in-situ carcinoma of the cervix or bladder, contralateral or ipsilateral in-situ breast cancer
•9. Other non-malignant systemic diseases that would prevent prolonged follow-up
•10. Patients who have had a bilateral oophorectomy or ovarian irradiation or are planning oophorectomy within 5 years
•11. History of noncompliance to medical regimens or considered potentially unreliable
•12. Patients who are pregnant or lactating at randomisation or who desire a pregnancy within 5 years. Patients planning to use additional hormone therapy (including contraceptives) during the next 5 years
•13. Previous endocrine therapy (neoadjuvant/adjuvant)

发起方

European Institute of Oncology (IEO) (Italy)