IBCSG 26-02 / BIG 4-02: Premenopausal Endocrine Responsive Chemotherapy Trial

Phase 3

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12605000419662
• Lead Sponsor: Australia and New Zealand Breast Cancer Trials Group Ltd

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: Stopped early
• Sex: Female
• Target Recruitment: 1750

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
To compare disease free survival between treatment arms.[At first confirmation of relapse (local, regional or distant), contralateral breast cancer, second (non-breast) primary tumour and/death.]

Secondary Outcome Measures

Name	Time	Method
To compare overall survival[At time of death from any cause];Systemic disease-free survival[At the time of systemic relapse, appearance of second (non-breast) primary tumour, or death, whichever occurs first.];Quality of life[6 years];Sites of first treatment failure[At the time of first treatment failure.];Late side effects of early menopause[At the time of menopause.];Incidence of second (non-breast) malignancies [At the time of incidence of second (non-breast) malignancies];Causes of death without cancer event between the treatment arms.[At the time of death]