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

NCT00739063 | Terminated Phase 2 Results

• 1 other identifier: 2006-0613
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Tarceva daily

EXPERIMENTAL

Tarceva oral 150 mg daily.

Drug: Tarceva

Interventions

Tarceva DRUG

Tarceva (erlotinib hydrochloride) given alone, at 150 mg by mouth daily.

Also known as: Erlotinib hydrochloride, OSI-774

Tarceva daily

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Patients with metastatic breast cancer to any distant site are eligible once their disease is clinically/radiologically measurable
• Patients must have disease which is resistant to taxanes and anthracyclines. There is no limit to the number of previous therapies for metastatic disease.
• Patients are eligible if they have not had prior exposure to an EGFR inhibitor (e.g.Gefitinib, Erlotinib) or antibody (e.g. Cetuximab).
• 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.
• 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.
• Patients with 'triple receptor-negative' metaplastic breast cancers are eligible if they meet the criterion of EGFR overexpression.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with institutional policy
• 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
• 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
• Patients should have adequate renal function (serum creatinine \</= 1.5 times the ULN)
• Negative pregnancy test for a woman of childbearing potential
• Women of childbearing potential must use a reliable and appropriate contraceptive method during the study
• Patients with a performance status of 2 or better by World Health Organization (W.H.O.)

You may not qualify if:

• Patients with uncompensated congestive cardiac failure are not eligible
• Patients with a myocardial infarction in the previous 12 months are not eligible
• Patients with central nervous system (CNS) metastases are not eligible
• Patients with an organ allograft
• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• OSI Pharmaceuticals: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ana Gonzalez-Angulo, MD, MS / Associate Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Bryan Hennessy, MD/Asst Prof

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 21, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 15, 2012
• Results First Posted: March 15, 2012

Record last verified: 2012-02

Locations

US (1)