Entry Detail
| General information | |
| Database: | DB00650 |
| Objective: | Approximately onethird of patients with advanced, human epidermal growth factor receptor 2+ve breast cancer (BC) develop brain metastases (BMs). The aim of this study is to investigate efficacy and tolerability of the combination of lapatinib and capecitabine (LC) in human epidermal growth factor receptor 2+ve BC patients with brain metastases (BCBM). |
| Authors: | Shawky H, et al |
| Title: | Alloral combination of lapatinib and capecitabine in patients with brain metastases from human epidermal growth factor receptor 2positive breast cancera phase II study. |
| Journal: | J Egypt Natl Canc Inst |
| Year: | 2014 |
| PMID: | 25294797 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | lapatinib |
| Target: | Epidermal growth factor receptor Receptor proteintyrosine kinase erbB2 |
| Cancer Type: | advanced cancer with brain metastasis |
| Cancer Subtype: | brain metastases from human epidermal growth factor receptor 2-positive breast cancerhuman epidermal growth factor receptor 2positive breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | lapatinib and capecitabine |
| Study Type: | a prospective singlearmphase II single institution study |
| Key Patients Feature: | age between 18 and70 years with human epidermal growth factor receptor 2+ve (defined as 3+ immunohistochemistry or evidence of gene amplification by fluorescence in situ hybridization) BC, Eastern Cooperative Oncology Group (ECOG)performance status (PS) of 6 2, adequate bone marrow reserve(WBC count P3.5 . 109/L, absolute neutrophil count ofP1.5 . 109/L, platelets P100 . 109/L, and hemoglobinP10 gm/dL), adequate renal function (measured creatinineclearance P60 mL/min) and adequate liver function (transaminases less than 2 . upper normal limit, and serum bilirubin concentrations below 1.5 mg/dL). |
| Biomarker: | human epidermal growth factor receptor 2+ve |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received lapatinib (1250 mg/day continuously) and capecitabine (2000 mg/m2 on days 114 of a 21day cycle). All patients were treated with trastuzumab either in the adjuvant or metastatic setting. No patients had received prior lapatinib and/or capecitabine. |
| Primary End Point: | response rate (RR), progression free survival (PFS), overall survival (OS) and toxicity. |
| Secondary End Point: | NA |
| Patients Number: | 21 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | The overall response rate (ORR) was 33.3% (7/21) and all were partial response. For patients receiving prior WBRT and patients receiving LC as first line treatment for BCBM the ORR was 31.2% (5/16) and 40.0% (2/5) respectively. |
| Disease Control Rate: | 0.629 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.5 months(Range; 1.1-22.0 months) |
| Median OS A vs. C: | 11 months |
| Adverse Event(agent arm): | Treatmentrelated adverse events were manageable. Grade 3-4 toxicities were handfoot syndrome (14.3%), diarrhea (14.3%), nausea/vomiting (9.5%), mucositis (4.8%), and skin rash (4.8%). |
| Conclusions: | The combination of LC is active and welltolerated treatment in patients with human epidermal growth factor receptor 2+ve BCBM. |