| General information |
| Database: | DB01070 |
| Objective: | Trastuzumab Emtansine Versus Trastuzumab Plus Docetaxel in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer |
| Authors: | Sara A. Hurvitz |
| Title: | Phase II randomized study of trastuzumab emtansine versus trastuzumab plus docetaxel in patients with human epidermal growth factor receptor 2positive metastatic breast cancer. |
| Journal: | journal of clinical oncology |
| Year: | 2013 |
| PMID: | 23382472 |
| Trial Design |
| Clinical Trial Id: | NCT00679341 |
| Agent: | Trastuzumab Emtansine
|
| Target: | human epidermal growth factor receptor 2 and microtubuleinhibitory
|
| Cancer Type: | breast cancer |
| Cancer Subtype: | breast cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | trastuzumab plus docetaxel |
| Study Type: | phase II, multicenter, openlabel study |
| Key Patients Feature: | more than and equal to 18 years of age with histologically or cytologically confirmed, human epidermal growth factor receptor 2positive, unresectable, locally advanced breast cancer and/or MBC without prior chemotherapy or trastuzumab for metastatic disease. human epidermal growth factor receptor 2positivity was defined as immunohistochemistry 3+(>10% cell staining) or fluorescent in situ hybridization-positive by local laboratory testing (ratio more than and equal to 2.0). Other inclusion criteria included measurable disease per ResponseEvaluation Criteria in SolidTumors(RECIST)version 1.0, 21 Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, and adequate organ function. |
| Biomarker: | human epidermal growth factor receptor 2positive |
| Biomark Analysis: | In this randomizedphase II study, firstline treatment with TDM1 for patients with human epidermal growth factor receptor 2positive MBC provided a significant improvement in PFS, with a favorable safety profile, versus HT. |
| Control Group Info: | Trastuzumab Emtansine monotherapy |
| Treatment Info: | TDM13.6 mg/kg intravenously(IV) once every3 weeks or trastuzumab 8 mg/kg IV loading dose followed by 6 mg/kg once every 3 weeks and docetaxel 75 or 100 mg/m2 (HT; per investigator discretion) IV once every 3 weeks. Treatment continued until progressive disease (PD) or unacceptable toxicity. |
| Primary End Point: | investigatorassessed progression free survival (PFS) and safety. |
| Secondary End Point: | overall survival (OS), objective response rate (ORR), duration of objective response, clinical benefit rate, and quality of life. |
| Patients Number: | 137 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | ORR was 58.0% (95% CI, 45.5% to 69.2%) with HT and 64.2% (95% CI, 51.8% to 74.8%) with TDM1. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.2 months with HT and 14.2 months with TDM1 (hazard ratio, 0.59; 95% CI, 0.36 to 0.97) |
| Median OS A vs. C: | A preliminary OS analysis was performed, with a median followup of approximately 23 months in both arms. |
| Adverse Event(agent arm): | TDM1 had a favorable safety profile versus HT, with fetheyr grade 3 adverse events (AEs; 46.4% v 90.9%), AEs leading to treatment discontinuations (7.2% v 40.9%), and serious AEs (20.3% v 25.8%). |
| Conclusions: | In this randomizedphase II study, firstline treatment with TDM1 for patients with human epidermal growth factor receptor 2positive MBC provided a significant improvement in PFS, with a favorable safety profile, versus HT. |