| General information |
| Database: | DB01023 |
| Objective: | Capecitabine Compared With Bevacizumab Plus Capecitabine in Patients With Previously Treated Metastatic Breast Cancer |
| Authors: | Kathy D. Miller |
| Title: | Randomizedphase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. |
| Journal: | journal of clinical oncology |
| Year: | 2005 |
| PMID: | 15681523 |
| Trial Design |
| Clinical Trial Id: | NCT00476827 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab plus capecitabine |
| Study Type: | This randomizedphase III trial compared the efficacy and safety of capecitabine with or without bevacizumab in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. |
| Key Patients Feature: | Women with histologically or cytologically confirmed MBC were eligible if they had received prior therapy with both an anthracycline and a taxane, and at least one, but no more than two, prior chemotherapy regimens for metastatic disease. If relapse occurred within 12 months ofcompleting adjuvant anthracycline and taxane therapy, patients were eligible without intervening chemotherapy. Patients with human epidermal growth factor receptor 2positive disease (3 protein expression by immunohistochemistry or gene amplification by fluorescence in situ hybridization) must have progressed following trastuzumab. Additional inclusion criteria included bidimensionally measurable disease with at least one lesion measuring 2 cm; Eastern Cooperative OncologyGroup performance status of0 or 1; and adequate renal, hepatic, and hematologic function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | capecitabine (2, 500 mg/m2/d) twice daily on day 1 through 14 every 3 weeks, alone |
| Treatment Info: | patients were randomly assigned to receive capecitabine (2, 500 mg/m2/d) twice daily on day 1 through 14 every 3 weeks, alone or in combination with bevacizumab (15 mg/kg) on day 1 |
| Primary End Point: | progression free survival (PFS), as determined by an independent review facility. |
| Secondary End Point: | NA |
| Patients Number: | 462 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | IRF (19.8% [95% CI, 14.7% to 25.0%] v 9.1% [95% CI, 5.4% to 12.9%]; P = .001) and the investigators (30.2% [95% CI, 24.3% to 36.1%] v 19.1% [95% CI, 14.1% to 24.2%]; P=.006). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.86 v 4.17 months; hazard ratio =0.98 |
| Median OS A vs. C: | 15.1 v 14.5 months |
| Adverse Event(agent arm): | The addition of bevacizumab did not affect the frequency or severity of capecitabine toxicities |
| Conclusions: | Bevacizumab was well tolerated in this heavily pretreated patient population. Although the addition of bevacizumab to capecitabine produced a significant increase in response rates, this did not translate into improved PFS or overall survival. |