• To learn if Tarceva® (erlotinib hydrochloride) can help control triple receptor-negative breast cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  

• The safety of this drug will also be studied. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  

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 growing.

Screening Tests:

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.

• Blood (about 5 teaspoons) will be drawn for routine tests.
• If you have had a biopsy at M. D. Anderson, your leftover tissue will be used to confirm the breast cancer is triple receptor-negative.
• If you have had a biopsy at another location, a part of that biopsy will be collected and tested to make sure that the breast cancer is triple receptor-negative.
• You will have imaging scans, such as computed tomography (CT) or bone scans, to check the status of the disease.
• If no tissue is available to check the status of the disease, you will have a breast biopsy. To collect a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tissue is withdrawn through a large needle.

Study Drug Dose Level:

If you are found to be eligible to take part in this study, you will take erlotinib hydrochloride by mouth once a day, every day, between breakfast and lunch. You should take erlotinib hydrochloride 1 hour before or 2 hours after eating. It should be taken at the same time each day.

Study Visits:

Every 8 weeks, the following tests and procedures will be performed:

• You will have a physical exam.
• Blood (about 5 teaspoons) will be drawn for routine tests.
• You will have the same imaging scans that were performed at screening to check the status of the disease.
• You will be asked about any side effects you may be experiencing.

Length of Study:

You may remain on this study for as long as you are benefiting. You will be taken off this study if the disease gets worse or intolerable side effects occur.

End-of-Study Visit:

You will have an end-of-study visit once you are off this study. The following tests and procedures will be performed at this visit.

• Blood (about 5 teaspoons) will be drawn for routine tests.
• You will have the same imaging scans repeated to check the status of the disease.

This is an investigational study. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of advanced lung cancer and advanced pancreatic cancer. Its use in breast cancer is investigational. Up to 50 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion:

1. Patients with histologic confirmation of metastatic(stage IV) 'triple receptor-negative' breast cancer. 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 or fluorescent in situ hybridization (FISH).
2. EGFR protein expression must be evaluated by immunohistochemistry on the primary tumor or a metastatic deposit with an anti-human EGFR,such as the mouse anti-human EGFR, clone 31G7 monoclonal antibody (Zymed Laboratories, San Francisco, CA) as described by Hirsch et al (1). The total EGFR score is calculated by multiplying the intensity score (0-4) and the fraction of positive cell (0-100%) producing a total range of 0-400 (Cappuzzo et al, 2). EGFR gene expression must be evaluated by FISH. Patients with an EGFR protein score of 201-400 or an EGFR gene amplification are eligible for the study.
3. Patients with metastatic breast cancer to any distant site are eligible once their disease is clinically/radiologically measurable
4. Patients must have disease which is resistant to taxanes and anthracyclines. There is no limit to the number of previous therapies for metastatic disease.
5. Patients are eligible if they have not had prior exposure to an EGFR inhibitor (e.g.Gefitinib, Erlotinib) or antibody (e.g. Cetuximab).
6. 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.
7. 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.
8. Patients with 'triple receptor-negative' metaplastic breast cancers are eligible if they meet the criterion of EGFR overexpression.
9. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy
10. 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
11. 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 x the ULN and alkaline phosphatase may be up to 5 x ULN
12. Patients should have adequate renal function (serum creatinine </= 1.5 times the ULN)
13. Negative pregnancy test for a woman of childbearing potential
14. Women of childbearing potential must use a reliable and appropriate contraceptive method during the study

Exclusion:

1. Patients with uncompensated congestive cardiac failure are not eligible
2. Patients with a myocardial infarction in the previous 12 months are not eligible
3. Patients with CNS metastases are not eligible
4. Patients with an organ allograft
5. 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