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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


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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small amount of tissue is withdrawn through a large needle.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.


Inclusion Criteria:



1. 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).

2. 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.

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 * the ULN and alkaline
phosphatase may be up to 5 * ULN

12. Patients should have adequate renal function (serum creatinine
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

15. Patients with a performance status of 2 or better by World Health Organization
(W.H.O.)

Exclusion Criteria:

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 central nervous system (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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP)

Outcome Description:

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.

Outcome Time Frame:

Baseline to disease progression, up to 22 months with follow up.

Safety Issue:

No

Principal Investigator

Bryan Hennessy, MD/Asst Prof

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0613

NCT ID:

NCT00739063

Start Date:

July 2008

Completion Date:

November 2010

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030