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

NCT01732276 | Unknown Phase 2 DMC

• 1 other identifier: 20120314
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Triple-negative breast cancer; Epidermal growth factor receptor; Gefitinib

Outcome Measures

Primary Outcomes (1)

• clinical benefit rate

  The primary end point is objective clinical benefit rate defined as objective response or stable disease for≥24wk

  one month

Secondary Outcomes (1)

• progress-free survival（PFS）

  every 4 weeks

Other Outcomes (1)

• Toxicity

  twice weekly

Study Arms (1)

gefitinib

EXPERIMENTAL

gefitinib tablet 250mg/day by mouth until disease progression

Drug: gefitinib

Interventions

gefitinib DRUG

Also known as: IRRESA

gefitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• brain metastasis

Sponsors & Collaborators

• Jiangmen Central Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• gengsheng yu

  Department of oncology, Jiangmen central hospital, Jiangmen, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gengsheng yu

CONTACT

0086-0750-3165915; gengsheng_yu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice director of oncology department, Jiangmen Central Hospital

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 3, 2012

Record last verified: 2012-11