IBCSG 24-02 / BIG 2-02: Suppression of Ovarian Function Trial

Phase 2

Active, not recruiting

• Conditions: Adjuvant Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12605000416695
• Lead Sponsor: Breast Cancer Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 3066

Inclusion Criteria

Pre-menopausal women with histologically proven, hormone receptor positive, completely resected breast cancer which is confined to the breast and axillary nodes without metastases; axillary node dissection or a negative axillary sentinel node biopsy; 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 or are planning oophorectomy within 5 years of entry; pregnant or lactating at randomization; 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 for more than 6 months after breast cancer diagnosis; tamoxifen or other SERM or HRT within 1 year prior to breast cancer diagnosis; patients who have received GnRH analogues as part of their breast cancer treatment prior to randomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival[ Disease free survival will be assessed annually starting when 200 events have been observed in the three treatment arms for a total of 5 analyses over 6.9 years.]