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. 2010 Aug 10;103(6):759–764. doi: 10.1038/sj.bjc.6605845

Table 1. Summary of the letrozole P024, IMPACT and PROACT trials.

  Letrozole P024 IMPACT PROACT
  Postmenopausal women with HR+ breast cancer
  337 randomised 330 randomised 451 randomised
Patient characteristics at baseline None were BCS candidates at baseline; 14% deemed inoperable Pretreatment surgical assessment available for 220 patients – 96 eligible for BCS 386 of the patients either required a mastectomy or were deemed inoperable at baseline
Definition of HR positivity ER/PgR staining >10% ER staining >1% ‘ER+/PgR+’
Neoadjuvant endocrine therapy L for 4 months T for 4 months A for 12 weeks A+T for 12 weeks T for 12 weeks A for 3 months T for 3 months
Concomitant chemotherapy? No Yes
Primary end point Clinical response by palpation Overall response by caliper measurements Overall response by ultrasound measurements
Response (per primary end point) 55% (L) vs 36% (T); P<0.001 37% (A) vs 39% (A+T) vs 36% (T) 39.5% (A) vs 35.4% (T)
Rate of down staging to BCS 45% (L) vs 35% (T); P=0.022 44%(A) vs 24% (A+T) vs 31% (T) 43.0% (A) vs 30.8% (T) in improved feasible surgery in hormone therapy-only group (n=314)

Abbreviations: A=anastrozole 1 mg daily; BCS=breast conserving surgery; ER=oestrogen receptor; HR=hormone receptor; IMPACT=Immediate Preoperative Anastrozole, Tamoxifen or Combined with Tamoxifen; L=letrozole 2.5 mg daily; PROACT=Preoperative ‘Arimidex’ Compared to Tamoxifen; PgR=progesterone receptor; T=tamoxifen 20 mg daily.