Cohort study evaluating efficacy of trastuzumab retreatment in recurrent breast cancer patients who previously received trastuzumab adjuvant therapy.
- Conditions
- Breast cancer
- Registration Number
- JPRN-UMIN000002738
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
Result Thirty-four patients were registered between July 2009 and June 2012. The median follow-up time was 23.7 months (2-24 months). The 1- and 2-year PFS rates were 46.9 (95% confidence interval (95% CI): 29.2-62.9%) and 29.8% (95% CI: 15.0-46.3%), respectively (median 10.6 months). The median PFS time for patients receiving trastuzumab combined with chemotherapy was 13.9 months. The 1-and 2-year overall survival rates were 93.9 (95% CI: 77.9-98.4%) and 84.8% (95% CI: 67.4-93.4%). Trastuzumab-induced grade 3/4 adverse events were not observed. Conclusion This study suggests that the PFS and OS in Japanese patients who relapsed after perioperative trastuzumab therapy were similar with those in previous reports. Differences in patient backgrounds and treatments must be considered when interpreting the results. Trastuzumab should be used combination with chemotherapy and/or hormonal therapy for retreatment. Retreatment with Trastuzumab is safe. (UMIN000002738)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 100
Not provided
Patients who meet ANY ONE of the following criteria are NOT eligible: (1)History of hypersensitivity to trastuzumab (2)Patients who are pregnant, lactating or with possibility of pregnancy (3)Stage IV at the first diagnosis (4)Patients with brain metastasis (5)Patients who were decided ineligible to this study from an investigator.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival; PFS
- Secondary Outcome Measures
Name Time Method Response rate, overall survival, safety