Status:
TERMINATED
Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
OSI Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if Tarceva® (erlotinib hydrochloride) can help control triple receptor-negative breast cancer. The safety of this drug will also be studied. Objec...
Detailed Description
The Study Drug: Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from g...
Eligibility Criteria
Inclusion
- Patients with histologic confirmation of metastatic (stage IV) 'triple receptor-negative' breast cancer. Tissue must be available at baseline or agree to biopsy. The diagnosis of 'triple receptor-negative' breast cancer requires that either the primary tumor or a metastatic deposit be shown to be negative for estrogen receptors (ER) and progesterone receptors (PR) by immunohistochemistry (IHC) and for HER2/neu by IHC (i.e. a score of 0 and 1+) or fluorescent in situ hybridization (FISH).
- EGFR protein expression and gene copy number will be evaluated on stored tissue sample at a later time. Unstained slides, a block, or agreement for biopsy is required for study participation.
- Patients with metastatic breast cancer to any distant site are eligible once their disease is clinically/radiologically measurable
- Patients must have disease which is resistant to taxanes and anthracyclines. There is no limit to the number of previous therapies for metastatic disease.
- Patients are eligible if they have not had prior exposure to an EGFR inhibitor (e.g.Gefitinib, Erlotinib) or antibody (e.g. Cetuximab).
- Availability of tissue blocks and/or fresh/frozen tumor samples is an eligibility requirement in order to run the EGFR IHC, FISH and to confirm, if needed ER, PR and HER2/neu status.
- Patients may, but are not required, to have a repeat tumor biopsy performed on study entry prior to beginning therapy and also early during study therapy for correlative studies.
- Patients with 'triple receptor-negative' metaplastic breast cancers are eligible if they meet the criterion of EGFR overexpression.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy
- Patients must have tissue blocks available from previous primary tumor surgery or biopsy or from a previous biopsy of metastatic disease for EGFR status assessment and for correlative studies
- Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of \>/= 1500/mm\^3, and a platelet count \>/= 100000/ mm\^3. Patients must have adequate liver function with a bilirubin within 1.5 times the upper limit of normal (ULN). Transaminases (SGPT) may be up to 5 \* the ULN and alkaline phosphatase may be up to 5 \* ULN
- Patients should have adequate renal function (serum creatinine \</= 1.5 times the ULN)
- Negative pregnancy test for a woman of childbearing potential
- Women of childbearing potential must use a reliable and appropriate contraceptive method during the study
- Patients with a performance status of 2 or better by World Health Organization (W.H.O.)
Exclusion
- Patients with uncompensated congestive cardiac failure are not eligible
- Patients with a myocardial infarction in the previous 12 months are not eligible
- Patients with central nervous system (CNS) metastases are not eligible
- Patients with an organ allograft
- Patients with a serious concurrent infection or illness including, but not limited to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00739063
Start Date
July 1 2008
End Date
November 1 2010
Last Update
March 15 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030