Methods |
Multicentre trial carried out in 41 hospitals in Norway. Randomisation was done by contacting a central trials office. Patients were randomised between January 1989 and July 1994. |
Participants |
320 women under 50 years of age were randomised. Women who were known to be ER‐ were excluded. 241 (75%) women were ER+. |
Interventions |
Women had undergone either mastectomy (n=255) or breast conservation (n=64). 140 women received radiotherapy and 235 received peri‐operative chemotherapy in accordance with local practice. Information on surgery was missing for one woman and information on peri‐operative chemotherapy was missing for one woman. The peri‐operative chemotherapy was vincristin 1mg iv, cyclophosphamide 400mg iv and 5‐flourouracil 500mg iv on d0 followed by vincristin 1mg iv, methotrexate 50mg iv and 5‐flourouracil 500mg iv on d7. Women were randomised to tamoxifen (20mg daily) for two years (n=161) versus goserelin (3.6mg sc every 28 days) for two years (n=159). |
Outcomes |
Primary outcome: recurrence.
Other outcomes: mortality. |
Notes |
Global quality rating: B1. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |