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Trial Title:
The Safety and Effects of Gefitinib in Triple-negative,EGFR Positive Metastatic Breast Cancer
NCT ID:
NCT01732276
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Gefitinib
Conditions: Keywords:
Triple-negative breast cancer
Epidermal growth factor receptor
Gefitinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
gefitinib
Arm group label:
gefitinib
Other name:
IRRESA
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
January 2013
Completion date:
October 2015
Lead sponsor:
Agency:
Jiangmen Central Hospital
Agency class:
Other
Source:
Jiangmen Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01732276
