| General information |
| Database: | DB01010 |
| Objective: | Thisphase II neoadjuvant trial evaluated bevacizumabdocetaxel and carboplatin in triplenegative breast cancer. |
| Authors: | Kim HR, et al |
| Title: | Multicentrephase II trial of bevacizumab combined with docetaxelcarboplatin for the neoadjuvant treatment of triplenegative breast cancer (KCSG BR0905). |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23380385 |
| Trial Design |
| Clinical Trial Id: | NCT01208480 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | triplenegative breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | bevacizumab combined with docetaxelcarboplatin |
| Study Type: | Multicentrephase II trial |
| Key Patients Feature: | Women with hormone receptor and human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2)negative, stage II/III breast cancer |
| Biomarker: | triplenegative |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received six cycles of 75 mg/m(2) docetaxel, carboplatin (AUC = 5) and 15 mg/kg bevacizumab every 21 days |
| Primary End Point: | pathological complete response (pCR) in breasts and axillary lymph nodes (ALN). |
| Secondary End Point: | NA |
| Patients Number: | 45 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 95% |
| Disease Control Rate: | 100% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most frequently reported grade 3/4 adverse events were neutropenia (84%, n = 38), febrile neutropenia (9%, n = 4) and vomiting (7%, n = 3). No cases of congestive heart failure (CHF) were reported. |
| Conclusions: | Neoadjuvant bevacizumab, docetaxel and carboplatin resulted in an encouraging pCR rate and negligible wound healing problems after surgery. |