Tamoxifen and Exemestane Trial

Phase 3

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast; Cancer; Breast Cancer

• Registration Number: ISRCTN66949472
• Lead Sponsor: International Breast Cancer Study Group (IBCSG)

Brief Summary

2014 Results article in https://www.ncbi.nlm.nih.gov/pubmed/24881463 results (added 09/09/2019)

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-18
• Study Completion: 2024-02-21
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2672

Inclusion Criteria

1. Pre-menopausal women (oestradiol [E2] levels in the premenopausal range), aged above 18 years
2. Histologically proven, resected breast cancer. Pathology material should be available for submission for central review.
3. Hormone receptor positive (HR+) tumour. HR must be determined using immunohistochemistry (IHC): oestrogen receptor (ER) and/or progesterone receptor (PgR) greater than or equal to 10%.
4. 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
5. Proper surgery (total mastectomy or breast conserving procedure plus radiation) for primary disease with no known clinical residual disease
6. Axillary lymph node dissection or negative axillary sentinel node biopsy
7. Written informed consent and accessible for follow-up
8. Patients must be informed of and agree to data and tissue transfer and handling, in accordance with national data protection guidelines

Exclusion Criteria

1. Postmenopausal
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
11. History of noncompliance to medical regimens or considered potentially unreliable
12. 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
13. Other non-malignant systemic diseases that would prevent prolonged follow-up

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival

Secondary Outcome Measures

Name	Time	Method
1. Causes of death without cancer event<br>2. Incidence of second (non-breast) malignancies<br>3. Late side effects of early menopause<br>4. Overall survival<br>5. Quality of life<br>6. Sites of first treatment failure<br>7. Systemic disease-free survival