The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer

This study is not yet open for participant recruitment.
Verified November 2012 by Jiangmen Central Hospital
Sponsor:
Information provided by (Responsible Party):
yu gengsheng, Jiangmen Central Hospital
ClinicalTrials.gov Identifier:
NCT01732276
First received: November 19, 2012
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

Breast cancer is a heterogeneous disease and can be classified into several distinctive subgroups. Triple-negative breast cancer(TNBC) is defined by lack of estrogen(ER), progesterone(PR) immunoreactivity and lack of human epidermal receptor-2(HER2) overexpression. TNBC comprises around 15% of all breast cancer and is characterized by its aggressive clinical behavior and insensitivity toward available targeted treatment strategies such as endocrine and anti-HER2 therapies.Although TNBC is sensitive to chemotherapy,early relapse with metastatic disease is common and the prognosis is poor. Development Of novel treatment strategies is,therefore,needed and the study of other potential targets in TNBC,like tyrosine kinase receptors,is a topic of interest.

Epidermal Growth Factor Receptor(EGFR) is a transmembrane receptor tyrosine kinase that encoded by cell erythroblastosis virus oncogene B1(C-erbB1) and belongs to the HER/Erythroblastosis virus oncogene B(ErbB) family. By several signal pathways,EGFR regulates cell proliferation, differentiation, apoptosis, invasion,and angiogenesis,and serves as a poor prognostic factor.EGFR is overexpressed in a variety of malignancies including TNBC.Gene expression profiling and immunohistochemical studies have indicated that 40 to 60% of TNBCs exhibit EGFR expression and gene amplification was found in 18% of this subgroup,but EGFR mutation was rare in TNBC.

By far,the role of gefitinib, an EGFR tyrosine kinase inhibitor(TKI),in the metastatic TNBC has not been identified. Most clinical trials about EGFR TKIs in the breast cancer have one or more limitations including:1) the study population had received heavily pretreatment; 2)the enrolled patients included several subgroups of breast cancer; 3)the expression of EGFR was not clear in the enrolled patients.

Here, the investigators launch a prospective clinical trial, and about 50 patients with triple-negative,EGFR positive metastatic breast cancer that have received at least second line therapy will be enrolled. these patients will be treated with gefitinib, the toxicity and effects of gefitinib will be recorded prospectively to evaluate the role of gefitinib in the metastatic TNBC.


Condition Intervention Phase
Breast Cancer
Drug: gefitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Jiangmen Central Hospital:

Primary Outcome Measures:
  • clinical benefit rate [ Time Frame: one month ] [ Designated as safety issue: No ]
    The primary end point is objective clinical benefit rate defined as objective response or stable disease for≥24wk


Secondary Outcome Measures:
  • progress-free survival(PFS) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
    Progress-free survival(PFS)is defined as the time from start of treatment to progression or death.


Other Outcome Measures:
  • Toxicity [ Time Frame: twice weekly ] [ Designated as safety issue: Yes ]
    Toxicity is assessed twice weekly and adverse effects(AEs) are classified according to the National Cancer Institute Common Toxicity Criteria(NCI-CTC).


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: gefitinib
gefitinib tablet 250mg/day by mouth until disease progression
Drug: gefitinib
Other Name: IRRESA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732276

Contacts
Contact: gengsheng yu 0086-0750-3165915 gengsheng_yu@hotmail.com

Sponsors and Collaborators
Jiangmen Central Hospital
Investigators
Principal Investigator: gengsheng yu Department of oncology, Jiangmen central hospital, Jiangmen, China
  More Information

No publications provided

Responsible Party: yu gengsheng, vice director of oncology department, Jiangmen Central Hospital, Jiangmen Central Hospital
ClinicalTrials.gov Identifier: NCT01732276     History of Changes
Other Study ID Numbers: 20120314
Study First Received: November 19, 2012
Last Updated: November 30, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangmen Central Hospital:
Triple-negative breast cancer
Epidermal growth factor receptor
Gefitinib

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014