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Phase Ⅱ Study of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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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

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