Table 1.
Selected clinical trials in the adjuvant setting for human epidermal growth factor receptor-2 positive breast cancer
| Drug or study name | Population included | No. of patients | Comparison | Median follow-up | DFS | OS | CHF/ Drop LVEF | Ref. |
| Trastuzumab (H) | ||||||||
| NCCTG N9831 | LN (+) or | 1087 | AC → T vs | 71.8% (5-yr) | 88.4% (5-yr) | 0%/0% | Perez et al[14] | |
| high risk LN (-) | 949 | AC → T → H (52 wk) vs AC | 72 mo | 80.1% (5-yr) | 89.7% (5-yr) | 2.2%/7% | ||
| 954 | → TH (H then 40 wk) | 84.4% (5-yr) | 91.9% (5-yr) | 1.5%/3.6% | ||||
| HERA | LN (+) or | 1552 | Std QT → H (52 wk) vs | 96 mo | 75.9% (5-yr) | 86.9% (5-yr) | 1%/7.2% | Goldhirsch et al[16] |
| high risk LN (-) | 1553 | Std QT → H (104 wk) vs | 76.5% (5-yr) | 88.7% (5-yr) | 0.8%/4.1% | |||
| 1697 | Std QT → Observation | 70.0% (5-yr) | 84.5% (5-yr) | 0.1%/0.9% | ||||
| FINHER | LN (+) or | 58 | Docetaxel → FEC vs | 62 mo | 74.1% (5-yr) | 82.0% (5-yr) | 1.7%/10.5% | Joensuu et al[18] |
| high risk LN (-) | 58 | Vinorelbine → FEC vs | 72.0% (5-yr) | 82.8% (5-yr) | (QT only) | |||
| 54 | Docetaxel + H → FEC vs | 92.5% (5-yr) | 94.4% (5-yr) | 0.9%/6.8% | ||||
| 61 | Vinorelbine + H → FEC | 75.2% (5-yr) | 88.4% (5-yr) | (QT + H) | ||||
| BCIRG 006 | LN (+) or | 1073 | AC → Docetaxel vs | 65 mo | 75% (5-yr) | 87% (5-yr) | 0.7%/11.2% | Slamon et al[19] |
| high risk LN (-) | 1074 | AC → Docetaxel + H vs | 84% (5-yr) | 92% (5-yr) | 2.0%/18.6% | |||
| 1075 | TCH | 81% (5-yr) | 91% (5-yr) | 0.4%/9.4% | ||||
| PACS 04 | LN (+) | 260 | FE100C or ED75 → Obser vs | 62 mo | 77.9% (3-yr) | 96% (3-yr) | 0.3%/14.2% | Spielmann et al[20] |
| 268 | FE100C or ED75 → H | 80.9% (3-yr) | 95% (3-yr) | 1.5%/35.4% | ||||
| PHARE | HER-2 (+) early breast cancer | 1690 | Std QT → H (26 wk) vs | 42.5 mo | 91.1% (2-yr) | 96.1% (2-yr) | 5.7% (both) | Pivot et al[21] |
| 1690 | Std QT → H (52 wk) | 93.8% (2-yr) | 94.5% (2-yr) | 1.9% (both) | ||||
| Lapatinib (L) | ||||||||
| TEACH | Stage I-IIIc – H naïve | 1230 (HER-2 +) | Std QT → L (52 wk) vs | 47.4 mo | 87% (4-yr) | 94% (4-yr) | 3.0% (both) | Goss et al[22] |
| 1260 (HER-2 +) | Std QT → Observation | 48.3 mo | 83% (4-yr) | 94% (4-yr | 3.0% (both) |
LN: Lymph nodes; AC → T: Adriamycin cyclophosphamide paclitaxel; FEC: 5-FU epirubicin cyclophosphamide; ED: Epirubicin docetaxel; Std QT: Standard chemotherapy; OS: Overall survival; DFS: Disease free survival; CHF: Cardiac heart failure; LVEF: Left ventricular ejection fraction.