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

• ClinicalTrials.gov Identifier: NCT01732276
• Recruitment Status: Unknown
• First Posted: November 22, 2012
• Last Update Posted: December 3, 2012
• Sponsor: Jiangmen Central Hospital
• Information provided by (Responsible Party): yu gengsheng, Jiangmen Central Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: gefitinib	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase Ⅱ Study of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer
• Study Start Date: January 2013
• Estimated Primary Completion Date: April 2015
• Estimated Study Completion Date: October 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: gefitinib; gefitinib tablet 250mg/day by mouth until disease progression	Drug: gefitinib; Other Name: IRRESA

Outcome Measures

Primary Outcome Measures :

1. clinical benefit rate [ Time Frame: one month ]
   The primary end point is objective clinical benefit rate defined as objective response or stable disease for≥24wk

Secondary Outcome Measures :

1. progress-free survival（PFS） [ Time Frame: every 4 weeks ]
   Progress-free survival（PFS）is defined as the time from start of treatment to progression or death.

Other Outcome Measures:

1. Toxicity [ Time Frame: twice weekly ]
   Toxicity is assessed twice weekly and adverse effects(AEs) are classified according to the National Cancer Institute Common Toxicity Criteria(NCI-CTC).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

• Responsible Party: yu gengsheng, vice director of oncology department, Jiangmen Central Hospital, Jiangmen Central Hospital
• ClinicalTrials.gov Identifier: NCT01732276
• Other Study ID Numbers: 20120314
• First Posted: November 22, 2012
• Last Update Posted: December 3, 2012
• Last Verified: November 2012

Keywords provided by yu gengsheng, 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; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action