Study | Duration (months) | Dose (mg/day) | No. of patients | Study outcomes | Assessment |
---|---|---|---|---|---|
P024 Trial Eiermann et al. 2001 [59] | 4 | Letrozole 2.5 or tamoxifen 20 | 324 | 1. pCR: 1.3% letrozole; 1.8% tamoxifen 2. ORR (clinical palpation): 55% letrozole; 36% tamoxifen (p < 0.0001). ER+subgroup: 60% letrozole; 41% tamoxifen. 3. BCS: 45% letrozole; 35% tamoxifen (p = 0.022) | Monthly clinical palpation and ultrasound. Mammography at baseline and prior to surgery. |
PROACT Cataliotti et al. 2006 [60] | 3 | Anastrozole 1 or tamoxifen 20 ± NCT | 451 | 1. pCR: NR. 2. ORR (clinical palpation): 49.7% anastrozole; 39.7% tamoxifen (p > 0.5, NET only) 3. BCS: 43% anastrozole; 30.8% tamoxifen (p = 0.04, NET only) | Ultrasound and caliper measurements at baseline and 3 months. |
IMPACT Smith et al. 2005 [19] | 3 | Anastrozole 1 or tamoxifen 20 or combination | 330 | 1. pCR: NR. 2. ORR (clinical palpation): 37% anastrozole; 36% tamoxifen; 39% combination (p = 0.87) 3. BCS: 44% anastrozole; 31% tamoxifen; 24% combination (p = 0.23, mastectomy at baseline) | Clinical caliper measurements and ultrasound at baseline, 2, 6 and 12 weeks. |
Akashi-Tanaka et al. 2007 [63] | 5 (Anastrozole) or 4 (Tamoxifen) | Anastrozole 1 or tamoxifen 20 | 45 | 1. pCR: not reported. 2. ORR (clinical palpation): 76.5% anastrozole; 46.4% tamoxifen 3. BCS: not reported. | Monthly clinical assessment. |
Semiglazov et al. 2005 [64] | 3 | Exemestane 25 or tamoxifen 20 | 151 | 1. pCR: 2.6% exemestane; 2.7% tamoxifen 2. ORR (clinical palpation): 76.3% exemestane; 40% tamoxifen (p = 0.05) 3. BCS: 36.8% exemestane; 20% tamoxifen (p = 0.05) | Not reported. |