| General information |
| Database: | DB01036 |
| Objective: | Bevacizumab in Combination with Trastuzumab and Capecitabine as FirstLine Treatment for HER2positive Locally Recurrent or Metastatic Breast Cancer |
| Authors: | MIGUEL MART¨ªN |
| Title: | Phase II study of bevacizumab in combination with trastuzumab and capecitabine as firstline treatment for HER2positive locally recurrent or metastatic breast cancer. |
| Journal: | The Oncologist |
| Year: | 2012 |
| PMID: | 22467666 |
| Trial Design |
| Clinical Trial Id: | NCT00811135 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 13 |
| Therapeutic Combination Content: | bevacizumab + trastuzumab and capecitabine |
| Study Type: | singlearm, openlabel, multicenter, phase II study, patients received bevacizumab plus trastuzumab plus capecitabine in IIIday cycles until disease progression, unacceptable toxicity, or withdrawal ofconsent. |
| Key Patients Feature: | aged more than and equal to 18 years with confirmed breast adenocarcinoma and measurable, LR, or metastatic lesions (according to the Response Evaluation Criteria in Solid Tumors [RECIST]). patients were required to have central laboratory documented HER2positive disease (immunohistochemistry 3 and/or fluorescence in situ hybridization positive and/or chromogenic in situ hybridization positive) and known estrogen receptor and progesterone receptor status. An Eastern Cooperative Oncology Group performance status score less than and equal to 2 and adequate bone marrow reserve and liver and renal function were also required. All patients were candidates for chemotherapy. |
| Biomarker: | HER2positive |
| Biomark Analysis: | The combination of bevacizumab, trastuzumab, and capecitabine was clinically active as firstline therapy for patients with HER2positive MBC, with an acceptable safety profile and no unexpected toxicities |
| Control Group Info: | single arm |
| Treatment Info: | bevacizumab (15 mg/kg on day 1) plus trastuzumab (8 mg/kg on day 1 of cycle 1, 6 mg/kg on day 1 of each subsequent cycle) plus capecitabine (1, 000mg/m2 twice daily, days 1-14) every 3weeks until disease progression, unacceptable toxicity, or consent withdrawal. |
| Primary End Point: | the best overall response rate (ORR). |
| Secondary End Point: | progression free survival (PFS), overall survival (OS), time to progression (TTP), and safety outcomes. |
| Patients Number: | 88 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 73% (95% confidence interval [CI], 62%-82%), comprising 7% complete and 66% partial responses. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 14.4 months (95% CI, 10.4 months to not reached [NR]) |
| Median OS A vs. C: | The median time to progression was 14.5 months (95% CI, 10.5 months to NR) |
| Adverse Event(agent arm): | main side effects were grade 3 hand-foot syndrome (22%), grade>3 diarrhea (9%), and grade>3 hypertension (7%). Overall, 44% ofpatients experienced grade>3 treatmentrelated adverse events and 13 patients discontinued capecitabine because of toxicity, but continued with bevacizumab and trastuzumab. Heart failure was seen in two patients. |
| Conclusions: | Thecombination ofbevacizumab, trastuzumab, and capecitabine was clinically active as firstline therapy for patients with HER2positive MBC, with an acceptable safety profile and no unexpected toxicities. |