The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Triple-negative breast cancer, Epidermal growth factor receptor, Gefitinib
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gefitinib
Arm Description
gefitinib tablet 250mg/day by mouth until disease progression
Outcomes
Primary Outcome Measures
clinical benefit rate
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)
Progress-free survival(PFS)is defined as the time from start of treatment to progression or death.
Full Information
NCT ID
NCT01732276
First Posted
November 19, 2012
Last Updated
November 30, 2012
Sponsor
Jiangmen Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01732276
Brief Title
The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer
Official Title
Phase Ⅱ Study of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangmen Central Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Triple-negative breast cancer, Epidermal growth factor receptor, Gefitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gefitinib
Arm Type
Experimental
Arm Description
gefitinib tablet 250mg/day by mouth until disease progression
Intervention Type
Drug
Intervention Name(s)
gefitinib
Other Intervention Name(s)
IRRESA
Primary Outcome Measure Information:
Title
clinical benefit rate
Description
The primary end point is objective clinical benefit rate defined as objective response or stable disease for≥24wk
Time Frame
one month
Secondary Outcome Measure Information:
Title
progress-free survival(PFS)
Description
Progress-free survival(PFS)is defined as the time from start of treatment to progression or death.
Time Frame
every 4 weeks
Other Pre-specified Outcome Measures:
Title
Toxicity
Description
Toxicity is assessed twice weekly and adverse effects(AEs) are classified according to the National Cancer Institute Common Toxicity Criteria(NCI-CTC).
Time Frame
twice weekly
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
gengsheng yu
Phone
0086-0750-3165915
Email
gengsheng_yu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
gengsheng yu
Organizational Affiliation
Department of oncology, Jiangmen central hospital, Jiangmen, China
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer
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