A randomized controlled trial evaluating resection of the primary breast tumor in women presenting with de novo stage IV breast cancer: Turkish Study (Protocol MF07-01).

Abstract

1005Background: The MF07-01 trial is a multicenter phase III randomized trial of treatment naive stage IV BC patients comparing loco-regional surgery (LRS) followed by appropriate systemic therapy (ST) vs ST alone. Aims: To compare 3-year survival and loco-regional progression (LRP). Methods: At initial diagnosis patients were randomized 1:1 to LRS group or ST group. After consideration of retrospective studies, we hypothesized at 36 months a survival difference between the two groups to be 18%. Assuming a 10% drop out rate and with a one sided log-rank test with a 95% CI and a 90% power 271 patients needed to be randomized. Results: 274 patients were accrued; 138 in the LRS group and 136 in the ST group. The groups were comparable regarding age, BMI, HER2 neu, tumor type and size, histologic grade, and bone and visceral metastasis (all p > 0.05). There were 76 (55%) deaths in the LRS group and 101 (74%) in the ST group during the median 40 (20-51) months follow-up. At 36 months the survival rate was simi...