Study of Erlotinib, Small Molecule Targeting Epidermal Growth Factor Receptor (EGFR) in Treatment of Patients w/EGFR-overexpressing 'Triple Receptor-negative' Metastatic Carcinoma of Breast That Progressed on Anthracyclines and Taxanes
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small amount of tissue is withdrawn through a large needle.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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression (TTP)
Time to progression calculated from the date of study entry to the date of disease progression or death. Progression of disease is defined by RECIST (Response Evaluation Criteria In Solid Tumors) criteria, as measurable increase in the smallest dimension of any target or not-target lesion, or the appearance of new lesions, since baseline. Confirmed response based on two tumor assessments (imaging) separated by at least 4 weeks.
Baseline to disease progression, up to 22 months with follow up.
No
Bryan Hennessy, MD/Asst Prof
Principal Investigator
UT MD Anderson Cancer Center
United States: Institutional Review Board
2006-0613
NCT00739063
July 2008
November 2010
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |