Clinical trial NCT00739063
Conditions: Breast Cancer
Keywords: Breast cancer Carcinoma of the breast Stage IV Triple receptor-negative Triple receptor-negative breast cancer Metastatic triple receptor-negative breast cancer Epidermal growth factor receptor EGFR EGFR-overexpressing GFR inhibitor erlotinib Erlotinib hydrochloride Erlotinib Tarceva OSI-774
Sponsor: M.D. Anderson Cancer Center
Start date: 2008-07-01; Completion date: 2010-11-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

Objectives:

To assess the clinical efficacy, biologic effects and safety of the EGFR inhibitor erlotinib in the treatment of patients with 'triple receptor-negative' metastatic carcinoma of the breast.

Primary endpoints:

1\) Time to progression (TTP)

Secondary endpoints:

1. clinical benefit rate as defined by complete and partial response and stable disease
2. overall survival (OS)
3. safety profile and tolerability of erlotinib
4. biologic correlative studies

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 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 To collect a tumor biopsy, the affected area is numbed with anesthetic, and a small amount of tissue is withdrawn through a large needle.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.

Arms: arm 1: Tarceva oral 150 mg daily.
Interventions: intervention 1: Tarceva
Intervention descriptions: intervention 1: Tarceva (erlotinib hydrochloride) given alone, at 150 mg by mouth daily.

Protocol documents: