IBCSG 25-02 / BIG 3-02: Tamoxifen and Exemestane Trial

Phase 3

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12605000418673
• Lead Sponsor: Australia and New Zealand Breast Cancer Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 2639

Inclusion Criteria

Pre-menopausal women with histologically proven, completely resected hormone receptor positive breast cancer confined to the breast and axillary nodes without metastases; axillary node dissection or a negative axillary sentinel node biopsy is required; geographically accessible for follow up; written informed consent provided.

Exclusion Criteria

Post-menopausal women; distant metastatic disease; locally advanced inoperable breast cancer; supraclavicular node involvement; enlarged internal mammary nodes; bilateral invasive breast cancer; positive final margins; clinically detectable residual axillary disease; history of prior ipsilateral or contralateral invasive breast cancer; previous or concomitant malignancy; other non-malignant systemic diseases that would prevent prolonged follow-up; bilateral oophorectomy or ovarian irradiation; pregnant or lactating at randomisation, desire a pregnancy within 5 years or plan to use additional hormone therapy during next 5 years (including hormonal contraception); neoadjuvant or adjuvant endocrine therapy after breast cancer diagnosis; tamoxifen or other SERM or HRT within 1 year prior to breast cancer diagnosis; prior neoadjuvant or adjuvant chemotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival (DFS) - defined as the time from randomisation to local (including recurrence restricted to the breast after breast conserving treatment), regional or distant relapse, contralateral breast cancer, appearance of a second (non-breast) primary tumour, or death from any cause, whichever occurs first. An appearance of ductal carcinoma in-situ (DCIS) or lobular carcinoma in-situ (LCIS) either in the ipsilateral or in the contralateral breast will not be considered as an event for DFS.[Disease free survival (DFS) - DFS will be assessed during four interim analyses and one final analysis. the target number of events for the final anlaysis is 396, and interim anlayses will be planned after 99 (25%), 158 (40%), 237 (60%) and 317 (80%) events have been observed.]