A phase III trial comparing adjuvant treatment with @entity18789 3M-Depot for 24 months with CMF chemotherapy in ER/PR + node + pre-perimenopausal @entity0 XXXX .

@entity1 @entity1665 @entity0 @entity12840 @entity391 @entity18789 @entity17079 @entity1349
UNASSIGNED: 533 Background: Recent studies proved that ovarian ablation with LHRH-analogues is not inferior to CMF-chemotherapy in pre-perimenopausal ER/PR+ @entity0 @entity1 (bc pts). METHODS: A randomized phase III trial in pre-perimenopausal bc pts (pT1-3, N+, M0, ER+ and/or PR+) tested the H0 hypothesis that a 2 y treatment with 8 injections of @entity18789 3M-depot (LAD 3M) was not inferior (> 10 % below CMF) to 6 double cycles of CMF (C 500-, M 40-, F 600 mg/sqm/ @entity12840 and 8 q4w). Primary endpoint was 2y- progression free survival (PFS), secondary were 5y- PFS, @entity1349 ( @entity1349 ), state of health and safety. Other parameters were E2 serum levels and menstrual status. This was a planned 2 y final (589/599 pts) and 5 y interim analysis (359/599 pts). RESULTS: Of 599 pts randomized 526 were eligible for per protocol analysis. 2y- PFS was 80.9 % (207/256, CMF) and 83.0 % (224/270, LAD 3M). The H0 hypothesis was rejected (p = 0.0002). In CMF 51 pts (49 ongoing /145) and in LAD 3M 58 pts (46 ongoing /154) showed 5y- PFS. Mean time to progression was 48.1    1.1 (LAD 3M) vs. 47.3   1.1 mths (CMF) (Kaplan-Meier, p = 0.866). @entity1349 was 98.7 % (152/154, LAD 3M) vs. 97.2 % (141/145, CMF, n.s.). SAEs were reported in 14/294 pts (4.8%, LAD 3M) vs. 27/295 pts (9.2%, CMF). CMF was more often associated with chemotherapy side effects like @entity391 , weakness, @entity1665 compared to LAD 3M which was associated with typical menopausal symptoms like hot flushes, sweating. CMF led to a longer time off work compared to LAD 3M (155  135d vs. 98  120d, p<0.001). LAD 3M led to a more rapid and persistent E2- and menstrual suppression. After 3 years cessation of menstruation was present in 43.7% and 44.9% in the LAD 3M and CMF group respectively. CONCLUSIONS: In HR+, N+, pre-perimenopausal bc pts 8 injections of LAD 3M were not inferior to six double cycles of @entity17079 ) with regard to PFS and @entity1349 . Side effects had a different profile with typical cytostatic associated adverse events and longer time off work in the CMF group. This study was sponsored by Takeda-Pharma, Germany. [Table: see text].
