Entry Detail
| General information | |
| Database: | DB01061 |
| Objective: | human epidermal growth factor receptor 2 extracellular domain levels are associated with progression free survival in patients with human epidermal growth factor receptor 2positive metastatic breast cancer receiving lapatinib monotherapy. |
| Authors: | Allan Lipton |
| Title: | Human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2) extracellular domain levels are associated with progression free survival in patients with human epidermal growth factor receptor 2positive metastatic breast cancer receiving lapatinib monotherapy. |
| Journal: | cancer |
| Year: | 2011 |
| PMID: | 21456017 |
| Trial Design | |
| Clinical Trial Id: | NCT00089999 |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Key Patients Feature: | human epidermal growth factor receptor 2positive patients with MBC who had not received trastuzumab previously. |
| Biomarker: | Human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2) extracellular domain levels |
| Biomark Analysis: | Patients with a more than and equal to 20% decrease from baseline of serum human epidermal growth factor receptor 2 at weeks 4, 8, 12, and 16 had a significantly increased ORR and prolonged PFS. Conversely, those with a more than and equal to 20% increase from baseline had a significantly lotheyr ORR and shorter PFS. |
| Control Group Info: | either 1500 mg lapatinib once daily or 500 mg lapatinib twice daily |
| Treatment Info: | Eligible patients were randomized to receive either 1500 mg lapatinib once daily or 500 mg lapatinib twice daily. |
| Primary End Point: | Disease state; progression free survival (PFS) ; Confirmed ORR |
| Secondary End Point: | NA |
| Patients Number: | 138 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | For patients achieving more than and equal to 20% decline in serum human epidermal growth factor receptor 2 (baseline to week 4), the ORR was significantly higher (24/52 = 46%) compared with those who did not have this decrease (9/73 = 12.3%) (P< .0001). for patients who experienced more than and equal to 20% increase in serum human epidermal growth factor receptor 2 (baseline to week 4), the ORR was significantly lotheyr (1/39 2.6%) compared with those who did not have this increase (32/86 37%) (P< .0001). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Patients who achieved more than and equal to 20% decrease from baseline of serum human epidermal growth factor receptor 2 at week 4 had a significantly longer median PFS of 28.4 weeks (95% confidence interval [CI], 20.736.1; n = 53) compared with 19.3 weeks (95% CI, 14.924.4; n = 78) for patients who did not experience the decrease (P = .016) . Patients who experienced more than and equal to 20% increase from baseline of serum human epidermal growth factor receptor 2 at week 4 had a significantly shorter median PFS of 16.1 weeks (95% CI, 8.419.2; n = 42) compared with 28.4 weeks (95% CI, 20.236.1; n = 89) for patients who did not have the increase (P < .001). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Significant decreases in serum human epidermal growth factor receptor 2 levels during the first 16 weeks of lapatinib monotherapy were associated with better clinical outcome (longer PFS and increased ORR) in human epidermal growth factor receptor 2positive MBC patients. |