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Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739063
Recruitment Status : Terminated (Poor Accrual)
First Posted : August 21, 2008
Results First Posted : March 15, 2012
Last Update Posted : March 15, 2012
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.


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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Tarceva Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Tarceva daily
Tarceva oral 150 mg daily.
Drug: Tarceva
Tarceva (erlotinib hydrochloride) given alone, at 150 mg by mouth daily.
Other Names:
  • Erlotinib hydrochloride
  • OSI-774

Primary Outcome Measures :
  1. Time to Progression (TTP) [ Time Frame: Baseline to disease progression, up to 22 months with follow up. ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 </= 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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739063

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United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
OSI Pharmaceuticals
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Principal Investigator: Bryan Hennessy, MD/Asst Prof UT MD Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00739063    
Other Study ID Numbers: 2006-0613
First Posted: August 21, 2008    Key Record Dates
Results First Posted: March 15, 2012
Last Update Posted: March 15, 2012
Last Verified: February 2012
Keywords provided by M.D. Anderson Cancer Center:
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
GFR inhibitor erlotinib
Erlotinib hydrochloride
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action