Table 4.
Maintenance for triple negative breast cancer
| IBCSG Trial 22, Oct. 2016 | CREATE-X trial, 2015 | |
| Study design | Phase III | Phase III |
| Accrual time | 2000-2012 | 2007-2012 |
| Number of patients | N: 1086 CM: 542 Obs: 539 | N: 910 X: 455 Obs: 455 |
| Setting | Prior adjuvant ± RT | Prior neoadyuvant ± RT |
| Study population | TNBC: 75% HER2+: 19% | Luminal or TNBC No pCR o node positive |
| Previous treatment | A + CMF: 60% CMF: 16% AT sequential + CMF: 26% H: 59% (of HER2+) | A: 4.1% AT sequential: 81% AT concurrently: 13.6% TC: 5% |
| Study treatment | C 50 mg/d PO Daily M 2.5 mg bid PO Days 1-2 vs Observation | X 1250 mg/m2 twice/d PO Day 1-14 Observation |
| Time of treatment | Every week for 1 yr | Every 3 wk for 8 cycles (6 mo) |
| DFS | 5 yr DFS: CM: 78.1% Obs: 74% HR = 0.84 (95%CI: 0.66 to 1.06; P = 0.14) TNBC: n = 814; HR = 0.80; 95%CI: 0.60-1.06 TNBC, node-positive disease: n = 340; HR = 0.72; 95%CI: 0.49-1.05 | 5 yr DFS: X: 74.1% Obs: 67.7% HR (95%CI): 0.70 (0.53-0.93); P = 0.00524 30% reduction in risk |
| OS | No results | 5 yr OS X: 89.2% Obs: 83.9%, P < 0.01 |
| Adverse events | Hipertransaminasemia G3-G4: 7% Leukopenia: 2% | X: HFS G3: 10.9% Neutropenia G3: 6.6% Diarrhea G3: 3% Obs: Neutropenia 1.6% Diarrhea: 0.4% |
C: Cyclophosmide; M: Methotrexate; X: Capecitabine; ER: Estrogen receptor; PR: Progesterone receptor; A: Anthracycline; F: 5Fluoracil; T: Taxane; TNBC: Triple negative breast cancer; H: Herceptin.