Study | Duration (months) | Dose (mg/day) | No. of patients | Study outcomes | Assessment |
---|---|---|---|---|---|
Rusz et al. 2015 [29] | 12 | Letrozole 2.5 | 42 | 1. pCR: 14.3% operated cases; 13% overall 2. ORR (clinical palpation): 88% 3. BCS: 45% | Clinical palpation every 3 months. Imaging as necessary. |
Carpenter et al. 2014 [30] | Up to 12 | Letrozole 2.5 | 139 | 1. pCR: not reported. 2. ORR (clinical palpation): 85% (3.2% CR and 81.5% PR) 3. BCS: 66% at 12 months (all ineligible at baseline) | Clinical examination and bimodal ultrasound every 2 months until BCS. |
Allevi et al. 2013 [27] | Randomized to 4, 8, or 12 | Letrozole 2.5 | 120 | 1. pCR: 2.5% 4 months; 5% 8 months and 17.5% 12 months. 2. ORR (clinical palpation): 45% 4 months; 86.8% 8 months; 95% 12 months. 3. BCS: 80% 4 months; 85% 8 months; 87.5% 12 months. | Monthly clinical palpation (caliper). Mammography and ultrasound at baseline and before surgery. |
Llombart-Cussac et al. 2012 [73] | 3 to 12 | Letrozole 2.5 | 70 | 1. pCR: 0% 2. ORR (clinical palpation): 76.8% (25% CR and 51.8% PR) 3. BCS: 43% | Monthly clinical examination. Mammogram and ultrasound every 8 weeks for first 4 months. |
Dixon et al. 2009 [71] | 3 to > 24 months | Letrozole 2.5 | 182 | 1. pCR: NR. 2. ORR (clinical palpation): 69.8% 3 months; 83.5% > 3 months. 3. BCS: 60% 3 months; 72% > 3 months. | Clinical measurement and ultrasound at 0, 2, 6, and 12 weeks. Mammogram at 0 and 12 weeks. 3 monthly review thereafter. |
Krainick-Strobel et al. 2008 [72] | 4 to 8 | Letrozole 2.5 | 32 | 1. pCR: NR. 2. ORR (clinical palpation): 55% 4 months; 72.4% 8 months. 3. BCS: 75.9% (all ineligible at baseline) | Monthly clinical examination, ultrasound and mammogram. |
TEAM IIA Fontein et al. 2014 [70] | 3 to 6 | Exemestane 25 | 102 | 1. pCR: 0.98% 2. ORR (clinical palpation): 58.7% 3 months; 68.3% > 3 months (p = 0.031). 3. BCS: feasibility improved 61.8% to 70.6%. | Monthly clinical palpation. 3 monthly MRI, mammogram or ultrasound. |
PTEX46 Hojo et al. 2013 [76] | 4 or 6 | Exemestane 25 | 52 | 1. pCR: 0% 4 months; 4% 6 months. 2. ORR (clinical palpation): 42.3% 4 months; 48% 6 months (p = 0.89). 3. BCS: 50% 4 months; 48% 6 months. | Monthly caliper measurement and toxicity assessment. Ultrasound and mammogram if progression suspected. |