Table 3.
Design | Age | Stage | ER/PR status | Axillary Surgery | Results LR |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NSABP B-21 [18] | RCT | ANY | T1a-bN0 | AD | 8y 16% vs. 3% | |||||||||
Toronto-BC trial [19] | RCT | ≥ 50 | T1-2N0 | NA | AD | 8y 17.6% vs. 3.5% | ||||||||
CALGB 9343 [3] | RCT | ≥ 70 | T1N0 | ER-positive | AD or AS | 12y 9% vs. 2% | ||||||||
PRIME II [2] | RCT | ≥ 65 | T < 3 cm N0 | ER/PR positive | AD or AS | 10y 9.5% vs. 0.9% | ||||||||
ABCSG 8 A [20] | RCT (2 × 2. With without tamoxifen. With/without radiation) | Post-menopausal | T ≤ 3 cm N0 | ER/PR positive | AD | 10y 7% vs. 2% | ||||||||
BASO 2 [21] | RCT (2 × 2. With without tamoxifen. With/without radiation) | < 70 | T1N0 | ER/PR positive | AD or AS | 5y 4% vs. 1% | ||||||||
Trials of radiotherapy omission in early breast cancer patients incorporating biomarkers | ||||||||||||||
Design | Age | Stage | ER/PR status | Axillary Surgery | Systemic treatment | Biomarker |
Results LR |
|||||||
LUMINA [22] | Prospective Cohort | ≥ 55 | T1N0 | ER/PR positive | SLNB or AD | Endocrine therapy | Ki67 ≤ 13.25% | 5y 2.3% | ||||||
IDEA [23] | Prospective Cohort | 50–70 | T1N0 | SLNB or AD | Endocrine therapy | Oncotype RS ≤ 18 | Completed accrual | |||||||
PRECISION [24] | Prospective Cohort | 50–75 | T1N0 | ER/PR positive | SLNB or AD | Endocrine therapy | PAM-50 low ROR | Completed accrual | ||||||
UK PRIMETIME [25] | Prospective Cohort | ≥ 60 | T1N0 | ER/PR positive | SLNB | Endocrine therapy | IHC4 + C | Completed accrual | ||||||
EXPERT [26] | Phase 3 RCT | ≥ 50 | T1N0 | ER/PR positive | SLNB or AD | Endocrine therapy | PAM-50 low ROR ≤ 60 | recruiting | ||||||
DEBRA [27] | Phase 3 RCT | 50–70 | T1N0 | ER/PR positive | SLNB or AD | Endocrine therapy | Oncotype Rs ≤ 18 | recruiting |