Baseline parameters | Fulvestrant + dovitinib (n = 47) | Fulvestrant + placebo (n = 50) | All patients (n = 97) |
---|---|---|---|
Patient demographics | |||
Median age (range), years | 63 (44–82) | 63 (38–82) | 63 (38–82) |
Median weight (range), kg | 66.5 (38.0–95.0) | 65.0 (41.0–135.5) | 66.0 (38.0–135.5) |
ECOG performance status, n (%) | |||
0 | 28 (59.6) | 28 (56.0) | 56 (57.7) |
1 | 18 (38.8) | 20 (40.0) | 38 (39.2) |
2 | 1 (2.1) | 2 (4.0) | 3 (3.1) |
FGF pathway amplified, n (%)a | |||
No | 32 (68.1) | 33 (66.0) | 65 (67.0) |
Yes | 15 (31.9) | 17 (34.0) | 32 (33.0) |
Presence of visceral disease, n (%)b | |||
No | 12 (25.5) | 20 (40.0) | 32 (33.0) |
Yes | 35 (74.5) | 30 (60.0) | 65 (67.0) |
Disease characteristics, n (%) | |||
Primary site of cancer | |||
Breast | 47 (100) | 50 (100) | 97 (100) |
Metastatic site of cancer | |||
Bone | 39 (83.0) | 36 (72.0) | 75 (77.3) |
Lymph nodes | 21 (44.7) | 26 (52.0) | 47 (48.5) |
Liver | 22 (46.8) | 16 (32.0) | 38 (39.2) |
Other | 19 (40.4) | 8 (16.0) | 27 (27.8) |
Adrenal | 3 (6.4) | 3 (6.0) | 6 (6.2) |
Breast | 0 | 1 (2.0) | 1 (1.0) |
Time from initial diagnosis of primary site to start of study drug | |||
<6 months | 0 | 0 | 0 |
6 to <12 months | 2 (4.3) | 4 (8.0) | 6 (6.2) |
12 to <24 months | 5 (10.6) | 8 (16.0) | 13 (13.4) |
≥24 months | 40 (85.1) | 38 (76.0) | 78 (80.4) |
De novo stage IV | 23 (48.9) | 24 (48.0) | 47 (48.5) |
FGF pathway–amplified | 9 (19.1) | 6 (16.0) | |
FGF pathway–nonamplified | 14 (29.8) | 16 (32.0) | |
Prior therapies, n (%) | |||
Antineoplastic therapyc | 47 (100) | 50 (100) | 97 (100) |
Surgery | 47 (100) | 50 (100) | 97 (100) |
Hormone therapy | 47 (100) | 50 (100) | 97 (100) |
Radiotherapy | 37 (78.7) | 38 (76.0) | 75 (77.3) |
Chemotherapy | 32 (68.1) | 32 (64.0) | 64 (66.0) |
Therapy type at last treatment | |||
Hormone therapy | 43 (91.5) | 48 (96.0) | 91 (93.8) |
Chemotherapy | 0 | 1 (2.0) | 1 (1.0) |
Other | 4 (8.5) | 1 (2.0) | 5 (5.2) |
Prior hormone therapies, n (%) | |||
Number of prior hormone regimens | |||
1 | 28 (59.6) | 36 (72.0) | 64 (66.0) |
2 | 17 (36.2) | 13 (26.0) | 30 (30.9) |
3 | 2 (4.3) | 1 (2.0) | 3 (3.1) |
Settingd | |||
Adjuvant/neoadjuvant setting | 38 (80.9) | 37 (74.0) | 75 (77.3) |
Therapeutic setting | 23 (48.9) | 24 (48.0) | 47 (48.5) |
Prevention | 4 (8.5) | 3 (6.0) | 7 (7.2) |
Regimen type | |||
Tamoxifen | 27 (57.4) | 21 (42.0) | 48 (49.5) |
Letrozole | 18 (38.3) | 23 (46.0) | 41 (42.3) |
Anastrozole | 16 (34.0) | 18 (36.0) | 34 (35.1) |
Exemestane | 8 (17.0) | 9 (18.0) | 17 (17.5) |
Othere | 1 (2.1) | 4 (8.0) | 5 (5.2) |