SWOG 0230 / IBCSG 34-05
SWOG 0230 / IBCSG 34-05 - Phase III Trial of LHRH Analogue Administration During Chemotherapy to reduce Ovarian Function Failure Following Chemotherapy in Early Stage, Hormone Receptor Negative Breast Cancer.
Australia and New Zealand Breast Cancer Trials Group
416 participants
Jun 1, 2006
Interventional
Conditions
Summary
The trial is evaluating whether the LHRH analogue goserelin, which temporarily suppresses ovarian function, can prevent permanent ovarian failure after chemotherapy in premenopausal women with hormone receptor-negative breast cancer.
Eligibility
Inclusion Criteria1
- Participants must be premenopausal (defined as the presence of cyclic menstruation within 6 weeks prior to randomisation or FSH (follicle stimulating hormone) and Oestradiol levels in the premenopausal range), have histologically confirmed diagnosis of operable stage I, II or IIIa hormone receptor negative disease. The planned treatment must include 3-8 months/cycles (pre or post operatively) of an alkylating agent (cyclophosphamide) that can be anthracycline based or non-anthracycline based. Participants receiving pre-operative chemotherapy can not be planned to receive post-operative chemotherapy. Participants receiving post-operative chemotherapy must be randomised within 84 days of definitive surgery.
Exclusion Criteria1
- Participants can not have received prior cytotoxic chemotherapy (for this breast cancer or other condition), oestrogens, antiestrogens, selective oestrogen receptor modulators (SERMs), aromatase inhibitors or hormonal contraception in the 3 months prior to randomisation.Participants can not have had prior malignancies accept for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been disease free for 5 years after treatment with curative intent.Women who are pregnant or lactating will be excluded from participation.
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Interventions
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).
Locations(1)
View Full Details on ANZCTR
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ACTRN12606000075583