Entry Detail
| General information | |
| Database: | DB01050 |
| Objective: | Lapatinib plus capecitabine in treating human epidermal growth factor receptor 2positive advanced breast cancer |
| Authors: | BingHe Xu |
| Title: | Lapatinib plus capecitabine in treating human epidermal growth factor receptor 2positive advanced breast cancer: efficacy, safety, and biomarker results from Chinese patients. |
| Journal: | Chinese journal of cancer |
| Year: | 2011 |
| PMID: | 21527065 |
| Trial Design | |
| Clinical Trial Id: | NCT00508274 |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Lapatinib plus capecitabine |
| Study Type: | a singlearm openlabel trial in which patients received lapatinib plus capecitabine. |
| Key Patients Feature: | women, 18 years of age or older, with pathologically confirmed invasive stage IIIB/IIIC or stage IV breast cancer with at least 1 measurable lesion according to response evaluation criteria in solid tumors (RECIST) criteria v1.0. Institutional review board approval was obtained, and each patient provided written informed consent. Documentation of human epidermal growth factor receptor 2 immunohistochemistry overexpression by (3+) or human epidermal growth factor receptor 2 amplification by fluorescence in situ hybridization was also required by the local or central laboratory. Patients must have received prior therapy with a taxane and/or an anthracycline and could have received prior trastuzumab. Additional inclusion criteria included Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1, life expectancy of at least 12 weeks, and left ventricle ejection fraction (LVEF) within the institutional range of normal as assessed by echocardiogram. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | Exploratory analyses of oncogenic mutations of PIK3CA suggested that of 38 patients providing a tumor sample, baseline PIK3CA mutation status was not associated with CBR (P = 0.639) or PFS (P = 0.989). |
| Control Group Info: | single arm |
| Treatment Info: | lapatinib (1250 mg once daily) and capecitabine (2000 mg/m 2 per day) on days 1 to 14 every 21 days. |
| Primary End Point: | clinical benefit rate (CBR). |
| Secondary End Point: | progression free survival (PFS), time to response (TTR), duration of response (DoR), central nervous system (CNS) as first site of relapse, and safety. |
| Patients Number: | 52 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.34 months (95% confidence interval, 4.939.82 months) |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common toxicities were palmarplantar erythrodysesthesia (59.6%), diarrhea (48.1%), rash (48.1%), hyperbilirubinemia (34.6%), and fatigue (30.8%). |
| Conclusions: | In summary, the present study, EGF109491, demonstrates that the combination of lapatinib plus capecitabine is active and welltolerated in a population of Chinese women with human epidermal growth factor receptor 2positive advanced breast cancer or MBC who have progressed following other treatments, including an anthracycline andor a taxane, with or without trastuzumab. |