| General information |
| Database: | DB01082 |
| Objective: | Thisphase II study evaluated the efficacy and safety/tolerability of sunitinib plus trastuzumab in patients with human epidermal growth factor receptor 2positive advanced breast cancer (ABC). |
| Authors: | Bachelot T, et al |
| Title: | Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. |
| Journal: | BMC Cancer |
| Year: | 2014 |
| PMID: | 24606768 |
| Trial Design |
| Clinical Trial Id: | NCT00243503. |
| Agent: | sunitinib, trastuzumab
|
| Target: | NA
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | human epidermal growth factor receptor 2positive advanced breast cancer (ABC) |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | sunitinib+ trastuzumab |
| Study Type: | activity and safety results from a phase II study |
| Key Patients Feature: | Eligible patients were female aged more than and equal to 18 years with histologically or cytologically proven, unresectable, locally recurrent or metastatic human epidermal growth factor receptor 2positive BC and measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | sunitinib 37.5 mg/day and trastuzumab administered either weekly (loading, 4 mg/kg; then weekly 2 mg/kg) or 3weekly (loading, 8 mg/kg; then 3weekly 6 mg/kg). |
| Treatment Info: | Eligible patients received sunitinib 37.5 mg/day and trastuzumab administered either weekly (loading, 4 mg/kg; then weekly 2 mg/kg) or 3weekly (loading, 8 mg/kg; then 3weekly 6 mg/kg). Prior trastuzumab and/or lapatinib treatment were permitted. |
| Primary End Point: | objective response rate (ORR). |
| Secondary End Point: | NA |
| Patients Number: | 60 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The ORR was 37%;Among patients who were treatmentna ve or had received only adjuvant therapy, the ORR was 44% |
| Disease Control Rate: | the clinical benefit rate (CBR; percent objective response plus stable disease more than and equal to 24 weeks) was 56%. Among patients who were treatmentna ve or had received only adjuvant therapy, the CBR was 59% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | Overall, median overall survival had not been reached and the 1year survival rate was 91%. |
| Adverse Event(agent arm): | The majority of adverse events (AEs) were mild to moderate in severity. Forty percent of patients experienced AEs related to measured left ventricular ejection fraction (LVEF) declines, which occurred more frequently in patients who had received prior anthracycline treatment. Ten percent of patients exhibited symptoms related to LVEF declines. One patient died on study from cardiogenic shock. |
| Conclusions: | Sunitinib plus trastuzumab demonstrated antitumor activity in patients with human epidermal growth factor receptor 2positive ABC, particularly those who they were treatmentna?ve or had only received prior adjuvant treatment. Sunitinib plus trastuzumab had acceptable safety and tolerability in patients with human epidermal growth factor receptor 2positive ABC who had not received prior anthracycline therapy. |