Table 2.
Clinical trials testing endocrine agents in the neoadjuvant setting that parallel results from studies conducted in the adjuvant or metastatic setting
| Presurgical and/or neoadjuvant trial | Time of Ki67 assessment (weeks) | Ki67 Outcome | Equivalent adjuvant or metastatic trial | ||
|---|---|---|---|---|---|
| NET Trials That Parallel Adjuvant Studies | |||||
|
IMPACT (25) (n: 259) |
2/12 | Ki67 geometric mean reduction Anastrozole: 76% at 2 wks/82% at 12 wks Tamoxifen: 59%/62% Tam + Ana: 64%/61% |
ATAC (n: 9366) (34) Anastrozole>Tamoxifen |
||
|
P024 (22) (n: 185) |
16 | Ki67 geometric mean reduction Letrozole: 87% Tamoxifen: 75% |
BIG 1–98 (n: 8010) (35) Letrozole>Tamoxifen |
||
|
ACOSOGZ1031 (30) (n: 266) |
16 | Ki67 geometric mean reduction Anastrozole: 79% Exemestane: 79% Letrozole: 82% |
MA.27 (n: 7576) (36) Anastrozole=Exemestane FACE (n: 4136) (37) Letrozole=Anastrozole |
||
|
STAGE (81) (n: 188) |
24 | Mean Ki67 (end of treatment) Anastrozole + Goserelin: 2.9% Tamoxifen + Goserelin: 8% |
SOFT (n: 4690) (82) Exemestane + OS>Tamoxifen + OS |
||
| NET Trials That Parallel Studies in Metastatic Disease | |||||
|
NEWEST (44) (n: 211) |
4/16 | Mean % change from baseline Fulvestrant 500 mg: 78% at 4 wks/77% at 16 wks Fulvestrant 250 mg: 44%/62% |
CONFIRM (n: 736) (45) Fulv 500 mg>Fulv 250 mg |
||
|
Baselga et al. (83) (n: 270) |
2 | Mean % change from baseline Exemestane + Everolimus: 90% Exe: 75% |
BOLERO-2 (n: 724) (84) Exemestane + Everolimus>Exemestane |
||
|
Smith et al. (49) (n: 206) |
2/16 | Mean % change from baseline Anastrozole + Gefitinib: 19% at 2 wks /77% at 16 wks Anastrozole: 43%/84% |
NCT00080743 (n: 290) (51) Anastrozole + Gefitinib>Anastrozole NCT00066378 (n: 71) (50) Tamoxifen + Gefitinib=Tamoxifen NCT00077025 (n: 93) (85) Anastrozole + Gefitinib=Anastrozole MINT (n: 359) (52) Anastrozole + AZD9831=Anastrozole |
||
|
Guarnieri et al. (86) (n: 92) |
24 | Mean Ki67 (end of treatment) Letrozole + Lapatinib :12.8% Letrozole: 12.8% |
NCT00073528 (n: 952) (87) Letrozole + Lapatinib=Letrozole |
||
|
OPPORTUNE (53) (n: 75) |
2 | Ki67 geometric mean reduction Anastrozole + Pictisilib: 83% Anastrozole: 66% |
FERGI trial (n: 129) (54) Fulvestrant + Pictisilib= Fulvestrant |
||
|
Curigliano et al. (88) (n: 14) |
2 | Mean % change from baseline Letrozole + Ribociclib: 92% Letrozole: 69% |
MONALEESA-2 (n: 668) (40) Letrozole + Ribociclib>Letrozole |
||
|
Ma et al. (39) (n: 45) |
2 | Complete cell cycle arrest (Ki67<2.7%) Anastrozole + Palbociclib: 86% Anastrozole: 26% |
PALOMA-2 (n: 666) (41) Letrozole + Palbociclib>Letrozole |
||
|
NEO-MONARCH (38) (n: 161) |
2 | Complete cell cycle arrest (Ki67<2.7%) Anastrozole: 15% Abemaciclib: 60% Anastrozole + Abemaciclib: 66% |
MONARCH-1 (n: 132) (43) High activity as monotherapy in ER+ breast cancer resistant to AIs |
||
NET: Neoadjuvant Endocrine Therapy; OS: Ovarian Suppression; AI: Aromatase Inhibitor