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 trialTime of Ki67 assessment (weeks)Ki67 outcomeEquivalent adjuvant or metastatic trial
NET trials that parallel adjuvant studies
 IMPACT (25)2/12Ki67 geometric mean reductionATAC (n = 9,366) (34)
 (n = 259)Anastrozole: 76% at 2 weeks/82% at 12 weeksAnastrozole > tamoxifen
Tamoxifen: 59%/62%
Tamoxifen + anastrozole: 64%/61%
 P024 (22)16Ki67 geometric mean reductionBIG 1-98 (n = 8,010) (35)
 (n = 185)Letrozole: 87%Letrozole > tamoxifen
Tamoxifen: 75%
 ACOSOG Z1031 (30)16Ki67 geometric mean reductionMA.27 (n = 7,576) (36)
(n = 266)Anastrozole: 79%Anastrozole = exemestane
Exemestane: 79%FACE (n = 4,136) (37)
Letrozole: 82%Letrozole = anastrozole
 STAGE (81)24Mean Ki67 (end of treatment)SOFT (n = 4,690) (82)
 (n = 188)Anastrozole + goserelin: 2.9%Exemestane + OS > tamoxifen + OS
Tamoxifen + goserelin: 8%
NET trials that parallel studies in metastatic disease
 NEWEST (44)4/16Mean % change from baselineCONFIRM (n = 736) (45)
 (n = 211)Fulvestrant 500 mg: 78% at 4 weeks/77% at 16 weeksFulvestrant 500 mg > fulvestrant 250 mg
Fulvestrant 250 mg: 44%/62%
 Baselga et al. (83)2Mean % change from baselineBOLERO-2 (n = 724) (84)
 (n = 270)Exemestane + everolimus: 90%Exemestane + everolimus > exemestane
Exemestane: 75%
 Smith et al. (49)2/16Mean % change from baselineNCT00080743 (n = 290) (51)
 (n = 206)Anastrozole + gefitinib: 19% at 2 weeks/77% at 16 weeksAnastrozole + gefitinib > anastrozole
Anastrozole: 43%/84%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)24Mean Ki67 (end of treatment)NCT00073528 (n = 952) (87)
 (n = 92)Letrozole + lapatinib: 12.8%Letrozole + lapatinib = letrozole
Letrozole: 12.8%
 OPPORTUNE (53)2Ki67 geometric mean reductionFERGI trial (n = 129) (54)
 (n = 75)Anastrozole + pictisilib: 83%Fulvestrant + pictisilib = fulvestrant
Anastrozole: 66%
 Curigliano et al. (88)2Mean % change from baselineMONALEESA-2 (n = 668) (40)
 (n = 14)Letrozole + ribociclib: 92%Letrozole + ribociclib > letrozole
Letrozole: 69%
 Ma et al. (39)2Complete cell-cycle arrest (Ki67 <2.7%)PALOMA-2 (n = 666) (41)
 (n = 45)Anastrozole + palbociclib: 86%Letrozole + palbociclib > letrozole
Anastrozole: 26%
 NEO-MONARCH (38)2Complete cell-cycle arrest (Ki67 <2.7%)MONARCH-1 (n = 132) (43)
 (n = 161)Anastrozole: 15%High activity as monotherapy in ER+ breast cancer resistant to AIs
Abemaciclib: 60%
Anastrozole + abemaciclib: 66%
  • Abbreviation: OS, ovarian suppression.