Table 1.
A | |||||||
EGF30008 [13]
HR+/HER2- pts (n = 644) |
|||||||
% (n°)
Overall Population |
mPFS (Months)
Overall Population |
mPFS (Months)
ET + LAPATINIB |
mPFS (Months)
ET + PBO |
||||
Lum A | 52 (335) | 16.9 (95% CI, 14.1–19.9) | NA | NA | |||
Lum B | 30 (196) | 11.0 (95% CI, 9.6–13.6) | NA | NA | |||
HER2E | 3 (16) | 4.7 (95% CI, 2.7–10.8) | NA | NA | |||
Basal-like | 3 (21) | 4.1 (95% CI, 2.5–13.8) | NA | NA | |||
Normal-like | 12 (76) | NA | NA | NA | |||
B | |||||||
PALOMA-2 [21]
All pts (n = 455) |
|||||||
% (n°)
Overall Population |
mPFS (Months)
Overall Population |
mPFS (Months)
LETRO + PALB |
mPFS (Months)
LETRO + PBO |
HR | |||
Lum A | 50.3 (229) | NA | 30.4 | 17.0 | 0.55 (95% CI, 0.39–0.77; p = 0.0005) |
||
Lum B | 29.7 (135) | NA | 16.9 | 11.0 | 0.51 (95% CI, 0.34–0.77; p = 0.0019) |
||
HER2E | 18.7 (85) | NA | NA | NA | NA | ||
Basal-like | 0.5 (2) | NA | NA | NA | NA | ||
Normal-like | 0.9 (4) | NA | NA | NA | NA | ||
C | |||||||
BOLERO-2 [15]
All pts (n = 261) |
|||||||
% (n°)
Overall Population |
% (n°)
Primary Tumors (n = 209#) |
% (n°)
Metastasis (N = 50#) |
mPFS (Months) Overall Population |
mPFS (Months)
EXE + EVE |
mPFS (Months)
EXE + PBO |
HR | |
Lum A | 46.7 (122) | 48.3 (101) | 40.0 (20) | 6.2 (95% CI, 4.37–8.31) |
8.3 (95% CI, 5.59–11.10) |
4.1 (95% CI, 2.63–5.26) |
0.39 (95% CI, 0.25–0.61; p < 0.0001) |
Lum B | 15.7 (41) | 14.8 (31) | 20.0 (10) | 5.4 (95% CI, 4.04–8.05) |
6.8 (95% CI, 4.11–11.70) |
2.8 (95% CI, 1.48–7.13) |
0.69 (95% CI, 0.34–1.39; p = 0.349) |
HER2E | 21.5 (56) | 18.7 (39) | 32.0 (16) | 5.2 (95% CI, 3.91–6.70) |
5.8 (95% CI, 3.91–7.36) |
4.1 (95% CI, 1.74–5.29) |
0.49 (95% CI, 0.26–0.90; p = 0.034) |
Basal-like | 1.9 (5) | 1.9 (4) | 2.0 (1) | 3.2 (95% CI, 1.51 to no result) |
NA | NA | NA |
Normal-like | 14.2 (37) | 16.3 (34) | 6.0 (3) | 6.8 (95% CI, 4.07–11.07) |
NA | NA | NA |
All Luminals | 62.4 (163) | 63.1 (132) | 60.0 (30) | 6.7 (95% CI, 4.40–8.05) |
8.7 (95% CI, 6.67–11.07) |
4.1 (95% CI, 2.66–4.37) |
0.37 (95% CI, 0.26–0.52; p < 0.0001) |
All Non-luminals | 37.6 (98) | 36.9 (77) | 40.0 (20) | 5.2 (95% CI, 3.45–6.70) |
5.8 (95% CI, 3.91–8.18) |
4.1 (95% CI, 2.76–5.29) |
0.47 (95% CI, 0.26–0.85; p = 0.027) |
D | |||||||
BOLERO-2 [15]
All pts (n = 261) |
|||||||
% (n°)
Overall Population |
mPFS (Months)
Overall Population |
mPFS (Months)
FULV + PALB |
mPFS (Months)
FULV + PBO |
HR | |||
Lum A | 44.0 (133) | NA | 16.6 | 4.8 | 0.41 (95% CI, 0.25–0.66) | ||
Lum B | 30.8 (93) | NA | 9.2 | 3.5 | 0.64 (95% CI, 0.38–1.09) | ||
HER2E | 20.9 (63) | NA | NA | NA | NA | ||
Basal-like | 1.7 (5) | NA | NA | NA | NA | ||
Normal-like | 2.6 (8) | NA | NA | NA | NA | ||
All Non-luminals | 25.2 (76) | NA | 9.5 | 5.5 | 0.58 (95% CI, 0.34–0.99) | ||
E | |||||||
MONALEESA-2 [24] | MONALEESA-3 [26] | MONALEESA-7 [28] | |||||
All pts (n = 358) | All pts (n = 489) | All pts (n = 313) | |||||
% (n°) | % (n°) | % (n°) | |||||
Lum A | 50.0 (179) | 48.7 (238) | 39.9 (125) | ||||
Lum B | 28.8 (103) | 19.6 (96) | 25.2 (79) | ||||
HER2E | 7.5 (27) | 14.9 (73) | 15.0 (47) | ||||
Basal-like | 2.5 (9) | 1.4 (7) | 4.5 (14) | ||||
Normal-like | 11.2 (40) | 15.3 (75) | 15.3 (48) | ||||
F | |||||||
All MONALEESA Trials [23]
All pts (n = 1160) |
|||||||
% (n°)
Overall Population |
% (n°)
Primary tumors (n = 835) |
% (n°)
Metastasis (N = 325) |
mPFS (Months) Overall Population |
mPFS (Months)
ET + RIBO |
mPFS (Months)
ET + PBO |
HR | |
Lum A | 46.7 (542) | 49.9 (417) | 38.1 (124) | NA | 29.60 (95% CI, 23.03 to no result) |
19.48 (95% CI, 15.61–24.80) |
0.63 (95% CI, 0.49–0.83; p < 0.001) |
Lum B | 24.0 (278) | 21.7 (181) | 30.5 (99) | NA | 22.21 (95% CI, 18.79 to no result) |
12.85 (95% CI, 10.84–14.82) |
0.52 (95% CI, 0.38–0.72; p < 0.001) |
HER2E | 12.7 (147) | 11.2 (93) | 16.8 (55) | NA | 16.39 (95% CI, 12.71–24.60) |
5.52 (95% CI, 3.12–9.17) |
0.39 (95% CI, 0.25–0.60; p < 0.001) |
Basal-like | 2.6 (30) | 2.4 (20) | 2.9 (9) | NA | 3.71 (95% CI, 1.91–13.00) |
3.58 (95% CI, 1.87 to no result) |
1.15 (95% CI, 0.46–2.83; p = 0.77) |
Normal-like | 14.0 (163) | 14.8 (124) | 11.7 (38) | NA | 22.34 (95% CI, 16.56 to no result) |
11.10 (95% CI, 7.39–16.56) |
0.47 (95% CI, 0.30–0.72; p < 0.001) |
# Biopsy source was unknown for two patients.