Trial Information
Phase Ⅱ Study of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer
Inclusion Criteria:
- ≥18 years of age
- ≥1 measurable or assessable lesion
- Eastern Cooperative Oncology Group(ECOG)performance status of 0-2
- adequate renal,hepatic and hematological function
- a life expectancy of >12 weeks
- histologically proven EGFR positive metastatic TNBC
Exclusion Criteria:
- brain metastasis
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
clinical benefit rate
Outcome Description:
The primary end point is objective clinical benefit rate defined as objective response or stable disease for≥24wk
Outcome Time Frame:
one month
Safety Issue:
No
Principal Investigator
gengsheng yu
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of oncology, Jiangmen central hospital, Jiangmen, China
Authority:
China: Food and Drug Administration
Study ID:
20120314
NCT ID:
NCT01732276
Start Date:
January 2013
Completion Date:
October 2015
Related Keywords:
- Breast Cancer
- Triple-negative breast cancer
- Epidermal growth factor receptor
- Gefitinib
- Breast Neoplasms