Entry Detail
| General information | |
| Database: | DB01066 |
| Objective: | sunitinib in combination with docetaxel and trastuzumab as firstline therapy for human epidermal growth factor receptor 2positive metastatic breast cancer |
| Authors: | Fatima Cardoso |
| Title: | An exploratory study of sunitinib in combination with docetaxel and trastuzumab as firstline therapy for human epidermal growth factor receptor 2positive metastatic breast cancer. |
| Journal: | The Breast |
| Year: | 2012 |
| PMID: | 23022045 |
| Trial Design | |
| Clinical Trial Id: | NCT00372424 |
| Agent: | sunitinib |
| Target: | FL cytokine receptor Mast/stem cell growth factor receptor Vascular endothelial growth factor receptor 2 Plateletderived growth factor receptor |
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 13 |
| Therapeutic Combination Content: | sunitinib + docetaxel and trastuzumab |
| Study Type: | Allocation: NonRandomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Key Patients Feature: | Eligible patients were female aged more than and equal to 18 years (Eastern Cooperative Oncology Group performance status 0/1) with histologically proven unresectable, locally recurrent or metastatic disease that was human epidermal growth factor receptor 2+ (defined as IHC 3+, FISH+, or CISH+) and measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | sunitinib plus docetaxel and trastuzumab. Sunitinib was administered at 37.5 mg/day for 2 weeks on treatment followed by 1 week off (Schedule 2/1). |
| Primary End Point: | safety; |
| Secondary End Point: | pharmacokinetics and antitumor activity. |
| Patients Number: | 25 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 73% 95% CI: 49.889.3 |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PFS (N= 25) was 58.9 weeks (95% confidence interval, 37.079.0). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common nonhematologic AEs of any grade were fatigue/asthenia (80%) and diarrhea (60%). In total, 22 patients (88%) reported a grade 3/4 AE. The most common grade 3 nonhematologic AEs were fatigue/asthenia (28%), diarrhea (16%), stomatitis/related oral syndromes (12%), vomiting (8%), and dyspnea (8%). |
| Conclusions: | Sunitinib combined with docetaxel and trastuzumab had an acceptable toxicity profile and showed preliminary antitumor activity as firstline treatment for metastatic human epidermal growth factor receptor 2+ breast cancer. |