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Herceptin
Clinical Pharmacology
Herceptin
The results for DFS for the integrated analysis of Studies 1 and 2, Study 3, and Study 4 are presented in Table 7. The duration of DFS for Studies 1 and 2 is presented in Figure 4, and the duration of DFS for Study 4 is presented in Figure 5. Across all four studies, there were insufficient numbers of patients within each of the following subgroups to determine if the treatment effect was different from that of the overall patient population: patients with low tumor grade, patients within specific ethnic/racial subgroups (Black, Hispanic, Asian/Pacific Islander patients), and patients > 65 years of age..
Figure 4: Duration of Disease-Free Survival in Patients with
Adjuvant Treatment of Breast Cancer (Studies 1 and 2)
 |
Figure 5: Duration of Disease-Free Survival in Patient with
Adjuvant Treatment of Breast Cancer (Study 4)
 |
Exploratory analyses of DFS as a function of HER2 overexpression or gene amplification were conducted for patients in Studies 2 and 3, where central laboratory testing data were available. The results are shown in Table 8. The number of events in Study 2 was small with the exception of the IHC 3+/FISH+ subgroup, which constituted 81% of those with data. Definitive conclusions cannot be drawn regarding efficacy within other subgroups due to the small number of events. The number of events in Study 3 was adequate to demonstrate significant effects on DFS in the IHC 3+/FISH unknown and the FISH +/IHC unknown subgroups.
Table 7: Treatment Outcomes in Studies 2 and 3 as a Function
of HER2 Overexpression or Amplification
| Study 2 | Study 3 | |||
| HER2 Assay Resulta | Number of Patients | Hazard Ratio DFS (95% CI) | Number of Patients | Hazard Ratio DFS (95% CI) |
| IHC 3+ | ||||
| FISH (+) | 1170 | 0.42 (0.27, 0.64) |
91 | 0.56 (0.13, 2.50) |
| FISH (- ) | 51 | 0.71 (0.04, 11.79) |
8 | ¯ |
| FISH Unknown | 51 | 0.69 (0.09, 5.14) |
2258 | 0.53 (0.41, 0.69) |
| IHC < 3+ /FISH (+) | 174 | 1.01 (0.18, 5.65) |
299b | 0.53 (0.20, 1.42) |
| IHC unknown /FISH (+) | ¯ | ¯ | 724 | 0.59 (0.38, 0.93) |
| a IHC by Hercep Test, FISH by Path Vysion (HER2/CEP17
ratio > 2.0) as performed ata centrallaboratory. bAll cases in this categoryin Study 3 were IHC 2+ . |
||||
Metastatic Breast Cancer
The safety and efficacy of Herceptin in treatment of women with metastatic breast cancer were studied in a randomized, controlled clinical trial in combination with chemotherapy (Study 5, n=469 patients) and an open-label single agent clinical trial (Study 6, n=222 patients). Both trials studied patients with metastatic breast cancer whose tumors overexpress the HER2 protein. Patients were eligible if they had 2 or 3 levels of overexpression (based on a 0 to 3 scale) by immunohistochemical assessment of tumor tissue performed by a central testing lab.
Previously Untreated Metastatic Breast Cancer (Study 5)
Generic Name: Trastuzumab
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