| General information |
| Database: | DB00986 |
| Objective: | they report safety data from a randomised, phase III study (CECOG/BC.1.3.005) evaluating firstline bevacizumab plus paclitaxel or capecitabine for locally recurrent or metastatic breast cancer. |
| Authors: | Lang I, et al |
| Title: | Safety results from a phase III study (TURANDOT trial by CECOG) of firstline bevacizumab in combination with capecitabine or paclitaxel for HER2negative locally recurrent or metastatic breast cancer. |
| Journal: | Eur J Cancer. |
| Year: | 2012 |
| PMID: | 22640829 |
| Trial Design |
| Clinical Trial Id: | NCT00600340 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | human epidermal growth factor receptor 2positive advanced breast cancer (ABC) |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab + capecitabine or paclitaxel |
| Study Type: | Safety results from a phase III study (TURANDOT trial by CECOG) |
| Key Patients Feature: | Patients aged more than and equal to 18 years with human epidermal growth factor receptor2negative breast adenocarcinoma |
| Biomarker: | HER2negative |
| Biomark Analysis: | NA |
| Control Group Info: | Arm A: bevacizumab + paclitaxel versus evacizumab +capecitabine |
| Treatment Info: | pts were randomised to Arm A: bevacizumab 10 mg/kg days 1 and 15; paclitaxel 90 mg/m(2) days 1, 8, and 15, every 4 weeks; or Arm B: bevacizumab 15 mg/kg day 1; capecitabine 1000 mg/m(2) b.i.d., days 114, every 3 weeks, until disease progression, unacceptable toxicity or consent withdrawal. |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 561 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | AEs considered treatmentrelated to bevacizumab or chemotherapy, were reported in 85.2% of patients in Arm A and 78.0% of patients in Arm B. A higher incidence of grade 3 AEs was seen in Arm A (51.4%) compared with Arm B (40.8%), as well as a higher frequency of related grade 3 AEs (44.0% versus 24.5%, respectively). Almost twice as many patients withdrew bevacizumab or chemotherapy treatment due to an AE in Arm A (28.2%) than in Arm B (14.8%) |
| Conclusions: | These findings are inline with safety data for bevacizumab plus paclitaxel or capecitabine, reported in previousphase III trials. |