SWOG 0230 / IBCSG 34-05

SWOG 0230 / IBCSG 34-05 is being conducted internationally by the South West Oncology Group (SWOG). The study is coordinated in Australia and New Zealand by the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG) who are participating in the study in conjunction with the International Breast Cancer Studies Group (IBCSG) collaboration. This study will evaluate the worth of ovarian function suppression (achieved by use of LHRH (lutenising hormone-releasing hormone) analogue (Goserelin)) in preventing premature ovarian failure in premenopausal patients receiving either standard chemotherapy or neo adjuvant chemotherapy as treatment for hormone receptor negative early breast cancer. SWOG 0230 / IBCSG 34-05 is an international, multicentre, randomised phase III clinical trial of 416 premenopausal women who have had histologically or cytologically confirmed, receptor-negative primary breast cancer. Women will be randomised in a 2-arm design to receive either of the following: a. Standard cyclophosphamide containing adjuvant b. LHRH analogue (Goserelin) plus Standard cyclophosphamide containing adjuvant Patients are stratified according to: * age (<40 verses 40-49) * Chemotherapy regimen: 3 months / 4 cycles of anthracycline-based verses 6 months / 8 cycles of anthracycline-based verses 6 months / 8 cycles of non anthracycline-based. Goserelin (Zoladex) 3.6mg depot, administered subcutaneously by injection, commences one week prior to the first chemotherapy dose and is administered once every 4 weeks for the duration of chemotherapy (3-6 months depending on chemotherapy regimen).