| Whole population (n = 94) | Arm A (no ESOM) (n = 32) | Arm B (lower dose ESOM) (n = 31) | Arm C (higher dose ESOM) (n = 31) |
---|---|---|---|---|
Median Age (years) | 52 (31-67) | 52 (31-66) | 50 (36-64) | 54 (33-67) |
Amenorrhea | Â | Â | Â | Â |
 Premenopausal | 30 (31.9 %) | 10 (31.3 %) | 11 (35.5 %) | 9 (29.0 %) |
 Postmenopausal | 64 (68.1 %) | 22 (68.8 %) | 20 (64.5 %) | 22 (71.0 %) |
Advanced or metastatic | Â | Â | Â | Â |
 de novo metastatic | 8 (8.5 %) | 1 (3.1 %) | 4 (12.9 %) | 3 (9.7 %) |
 Metastatic | 86 (91.5 %) | 31 (96.9 %) | 27 (87.1 %) | 28 (90.3 %) |
  Median DFI (years) | 3.3 | 3.2 | 3.2 | 3.4 |
No. of metastatic sites | Â | Â | Â | Â |
 1 | 23 (24.5 %) | 10 (31.3 %) | 6 (19.4 %) | 7 (22.6 %) |
 2 | 37 (39.4 %) | 9 (28.1 %) | 15 (48.4 %) | 13 (41.9 %) |
 ≥3 | 34 (36.2 %) | 13 (40.6 %) | 10 (32.3 %) | 11 (35.5 %) |
Metastatic sites | Â | Â | Â | Â |
 Visceral | 69 (73.4 %) | 25 (78.1 %) | 22 (71.0 %) | 22 (71.0 %) |
  Lung | 50 (53.2 %) | 18 (56.3 %) | 16 (51.6 %) | 16 (51.6 %) |
  Liver | 39 (41.5 %) | 15 (46.9 %) | 11 (35.5 %) | 13 (41.9 %) |
 Nonvisceral | 25 (26.6 %) | 7 (21.9 %) | 9 (29.0 %) | 9 (29.0 %) |
  Bone | 38 (40.4 %) | 10 (31.3 %) | 15 (48.4 %) | 13 (41.9 %) |
ER status | Â | Â | Â | Â |
 Positive | 61 (64.9 %) | 19 (59.4 %) | 22 (71.0 %) | 20 (64.5 %) |
 Negative | 33 (35.1 %) | 13 (40.6 %) | 9 (29.0 %) | 11 (35.5 %) |
PR status | Â | Â | Â | Â |
 Positive | 57 (60.6 %) | 20 (62.5 %) | 18 (58.1 %) | 19 (61.3 %) |
 Negative | 37 (39.4 %) | 12 (37.5 %) | 13 (41.9 %) | 12 (38.7 %) |
HER-2 status | Â | Â | Â | Â |
 Positive | 15 (16.0 %) | 4 (12.5 %) | 5 (16.1 %) | 6 (19.4 %) |
 Negative | 79 (84.0 %) | 28 (87.5 %) | 26 (83.9 %) | 25 (80.6 %) |
Prior chemotherapy | Â | Â | Â | Â |
 Adjuvant/neoadjuvant |  |  |  |  |
  Anthracyclines only | 34 (36.2 %) | 12 (37.5 %) | 11 (35.5 %) | 11 (35.5 %) |
  Taxanes only | 2 (2.1 %) | 0 (0 %) | 1 (3.2 %) | 1 (3.2 %) |
  Both antracyclines and taxanes | 41 (43.6 %) | 16 (50.0 %) | 12 (38.7 %) | 13 (41.9 %) |
  others | 6 (6.4 %) | 0 (0 %) | 3 (9.7 %) | 2 (6.5 %) |
 None | 11 (11.7 %) | 4 (12.5 %) | 4 (12.9 %) | 4 (12.9 %) |
Prior endocrine therapy | Â | Â | Â | Â |
 1 | 44 (46.8 %) | 15 (46.9 %) | 13 (41.9 %) | 16 (51.6 %) |
 2 | 19 (20.2 %) | 5 (15.6 %) | 9 (29.0 %) | 5 (16.1 %) |
 ≥3 | 5 (5.3 %) | 2 (6.3 %) | 2 (6.5 %) | 1 (3.2 %) |
 None | 26 (27.7 %) | 10 (31.3 %) | 7 (22.6 %) | 9 (29.0 %) |
Subgroup | Â | Â | Â | Â |
 Triple negative | 15 (16.0 %) | 7 (21.9 %) | 2 (6.5 %) | 6 (19.4 %) |
 Her-2 positive | 11 (11.7 %) | 3 (9.4 %) | 5 (16.1 %) | 3 (9.7 %) |
 Luminal Type | 68 (72.3 %) | 22 (68.8) | 24 (77.4) | 22 (71.0) |