| General information |
| Database: | DB01028 |
| Objective: | Final results of a phase II study of nabpaclitaxel, bevacizumab, and gemcitabine as firstline therapy for patients with human epidermal growth factor receptor 2negative metastatic breast cancer. |
| Authors: | Christopher Lobo |
| Title: | Final results of a phase II study of nabpaclitaxel, bevacizumab, and gemcitabine as firstline therapy for patients with human epidermal growth factor receptor 2negative metastatic breast cancer. |
| Journal: | Breast Cancer Res Treat |
| Year: | 2010 |
| PMID: | 20585851 |
| Trial Design |
| Clinical Trial Id: | NCT00503906 |
| 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: | nabpaclitaxel, bevacizumab, and gemcitabine |
| Study Type: | singlecenter, openlabelphase II trial |
| Key Patients Feature: | Male and nonpregnant female patients who were more than and equal to 18 years of age, with measurable (by response evaluation criteria in solid tumors, RECIST) human epidermal growth factor receptor 2/neu nonoverexpressing or nonamplified (by FISH) MBC were eligible for this study. patients were required to have a life expectancy greater than 3 months, with an ECOG performance status of 0 or 1. Eligibility criteria included treatmentna ¡§ve, newly diagnosed MBC or patients with metastasis diagnosed more than and equal to 6 months after completing primary systemic treatment in the neoadjuvant or adjuvant setting. Patients with estrogen receptorpositive breast cancer who progressed on prior endocrine treatment in the adjuvant and/or palliative settings were eligible. |
| Biomarker: | human epidermal growth factor receptor 2negative |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | gemcitabine 1500 mg/m2, nabpaclitaxel 150 mg/m2, and bevacizumab 10 mg/kg (each administered intravenously) on days 1 and 15 of a 28day cycle. |
| Primary End Point: | progression free survival (PFS); |
| Secondary End Point: | overall response rate (ORR), complete (CR) and partial (PR) response rates, clinical benefit (ORR + stable disease), overall survival (OS), and safety. |
| Patients Number: | 30 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | ORR was 75.9%, comprising eight (27.6%) CRs and 14 (48.3%) PRs; five patients had stable disease (SD) and two patients (6.9%) had progressive disease (PD) as their best response. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PFS was 10.4 months (95% CI: 5.6-15.2 months). |
| Median OS A vs. C: | The 18month survival rate was 77.2% (95% CI: 51.1-90.5%). |
| Adverse Event(agent arm): | Eight (27.6%) patients experienced grade 3 or 4 toxicity: grade 4 neutropenic fever (n = 1) and grade 3 infection (n = 6), leukopenia, thrombocytopenia, peripheral neuropathy, seizure, shortness of breath, hematuria, and cardiac tamponade (one each). |
| Conclusions: | Firstline therapy with nabP, B, and G demonstrated a median PFS of 10.4 months and a 75.9% ORR with acceptable toxicity; this novel combination warrants investigation in a randomized study. |