Suppression of Ovarian Function Trial

Phase 3

Completed

Conditions: Topic: National Cancer Research Network
Subtopic: Breast Cancer
Disease: Breast
Cancer
Breast cancer

Registration Number: ISRCTN73368402

Lead Sponsor: European Institute of Oncology (IEO) (Italy)

Brief Summary: 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 3066

Inclusion Criteria

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

Exclusion Criteria

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)