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Table 1. Response to estrogen deprivation/SERMs in the neoadjuvant setting EGFR/HER2 Negative EGFR/HER2 Positive Study 1 Study 2 Study 3 Ellis (117) Zhu (118) Smith (11) Letrozole Tamoxifen Letrozole Tamoxifen Letrozole Tamoxifen 54% 42% 35% - 41% 43% 88% 21% 75% - 58% 22% 36
Table 2. Selected recent ongoing and completed phase II/III clinical trials inhibitors of HER family receptors in combination with endocrine therapy. Trial Design Disease Setting Trial Phase Primary Endpoints Outcomes Gefitinib Tamoxifen ± gefitinib Metastatic II RCT TTP Completed Anastrazole ± gefitinib (178) Gefitinib ± Anastrazole (169)* Gefitinib ± anastrazole Gefitinib + anastrazole vs. Gefitinib + fulvestrant Lapatinb Lapatinib + tamoxifen Metastatic 2nd line Neoadjuvant II RCT ORR NS ORR favoring the AI alone instead of the combination Neoadjuvant II RCT ↓ Ki67 labeling index ↓ in tumor size Metastatic II RCT TTP Ongoing Metastatic II RCT ORR Ongoing II ORR/CBR Ongoing Lapatinib ± letrozole Metastatic III RCT TTP Ongoing Lapatinib ± fulvestrant Trastuzumab Trastuzumab + letrozole (176) Anastrazole vs. Anastrazole + trastuzumab (177) Trastuzumab + exemestane Metastatic II RCT ORR/PK Ongoing ↓ Ki67 labeling index 98% vs. 92.4% ↓ in tumor size no difference Metastatic II ORR/TTP ORR 26% TTP 5.5 months Metastatic III ORR/TTP TTP 2.4mo vs. 4.8mo ORR 6.8% vs. 20.3% Metastatic II TTP Completed RCT=randomized controlled trial; ORR= objective response rate; CBR= clinical benefit rate; NS=not significant Tam=tamoxifen; PK= pharmacokinetics; * only in EGFR-positive patients. Also see information in Johnston et al.(83). 37
Page 1 and 2: Endocrine Reviews. First published
Page 3 and 4: Introduction Breast cancer evolutio
Page 5 and 6: endocrine therapy, might lead to th
Page 7 and 8: (also known as estrogen response el
Page 9 and 10: weaken the inhibitory effects of va
Page 11 and 12: that it is the E domain at the C-te
Page 13 and 14: independent or tamoxifen-mediated a
Page 15 and 16: (Iressa), which can block signaling
Page 17 and 18: that HER2-positive breast cancer is
Page 19 and 20: cases that received letrozole had a
Page 21 and 22: preclinical model (102). Furthermor
Page 23 and 24: suppressed/reduced PgR levels may d
Page 25 and 26: PgR-negative tumors have more aggre
Page 27 and 28: consequence of reversing ER-induced
Page 29 and 30: gefitinib combined with estrogen de
Page 31 and 32: performed in one of these trials, c
Page 33 and 34: advanced breast cancer have recentl
Page 35: act alone to stimulate tumor growth
Page 39 and 40: estrogen receptor (MNAR), can activ
Page 41 and 42: REFERENCES 1. Group EBCTC 1998 Tamo
Page 43 and 44: 13. De Laurentiis M, Arpino G, Mass
Page 45 and 46: 27. Klinge CM 2001 Estrogen recepto
Page 47 and 48: 42. Schiff R, Massarweh S, Shou J,
Page 49 and 50: antiestrogen-dependent membrane-ini
Page 51 and 52: 70. Pedram A, Razandi M, Aitkenhead
Page 53 and 54: 84. Bunone G, Briand PA, Miksicek R
Page 55 and 56: antihormone response and prevents d
Page 57 and 58: 110. Berry DA, Muss HB, Thor AD, Dr
Page 59 and 60: of hormonal status and HER-2 in bre
Page 61 and 62: 134. Daniel AR, Qiu M, Faivre EJ, O
Page 63 and 64: 146. Baehner FL Quantitative RT-PCR
Page 65 and 66: 158. Massarweh S, Shou J, DiPietro
Page 67 and 68: 169. Polychronis A, Sinnett HD, Had
Page 69 and 70: Antonio Breast Cancer Symposium (ab
Page 71 and 72: Figure 1 B Non-Classical Nuclear Ac
Page 73: Figure 3 ER+PR+ ER+PR-

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