Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery
NCT ID: NCT00633750
Last Updated: 2012-09-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2002-08-31
2007-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with breast cancer that can be removed by surgery.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary
* To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as measured by a reduction in Ki67 and/or an increase in terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL)-positive tumor cells in patients with treatment-naive, operable breast cancer.
Secondary
* To identify a molecular profile, based on measurements of Estrogen Receptor (ER), Epidermal Growth Factor Receptor (EGFR), and a Human Epithelial Growth Factor Receptor-2(HER2), and protein expression profiles in patients with treatment-naïve, operable breast cancer that is responsive to erlotinib hydrochloride.
* To correlate tumor concentrations of erlotinib hydrochloride with serum levels immediately before surgery.
OUTLINE: This is a multi-center study.
Patients receive oral erlotinib hydrochloride once daily for 5-14 days. Patients then undergo surgical resection within 24 hours after the last dose of erlotinib hydrochloride.
Tumor tissue samples are collected at baseline and during surgery for correlative laboratory studies. Tissue samples are stained for ER, HER2, and EGFR levels, proliferation (Ki67), and apoptosis (TUNEL) by immunohistochemistry. Levels of erlotinib hydrochloride in tissue samples are measured by matrix-assisted laser desorption/ionization mass spectrometry. Blood samples are collected on the day of surgery. Levels of erlotinib hydrochloride in blood samples are measured by liquid chromatography/mass spectrometry.
Patients are followed within 6 weeks after surgery.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tarceva
erlotinib hydrochloride
Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
TUNEL assay
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
protein expression analysis
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
immunohistochemistry staining method
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
laboratory biomarker analysis
Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
liquid chromatography
Used to determine blood plasma levels of Erlotinib on the day of surgery
mass spectrometry
Used to determine blood plasma levels of Erlotinib on the day of surgery
matrix-assisted laser desorption ionization mass spectrometry
After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
therapeutic conventional surgery
Surgical treatment will occur within 24-hours following completion of therapy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
erlotinib hydrochloride
Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
TUNEL assay
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
protein expression analysis
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
immunohistochemistry staining method
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
laboratory biomarker analysis
Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
liquid chromatography
Used to determine blood plasma levels of Erlotinib on the day of surgery
mass spectrometry
Used to determine blood plasma levels of Erlotinib on the day of surgery
matrix-assisted laser desorption ionization mass spectrometry
After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
therapeutic conventional surgery
Surgical treatment will occur within 24-hours following completion of therapy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis may be made by fine needle aspiration cytology or core biopsy
* A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining
Exclusion Criteria
* Locally advanced disease includes any of the following:
* Primary tumor ≥ 5 cm (T3)
* Tumor of any size with direct extension to the chest wall or skin (T4a-c)
* Inflammatory breast cancer (T4d)
* Fixed axillary lymph node metastases (N2)
* Metastasis to ipsilateral internal mammary node (N3) NOTE: \*Patients with primary tumors ≥ 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible
* Measurable residual tumor at the primary site
* Measurable disease is defined as any mass that can be reproducibly measured by physical examination
* Planning to undergo surgical treatment with either segmental resection or total mastectomy
* Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer
* No locally recurrent breast cancer
* No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* ANC ≥ 1,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) ≤ 1.5 times ULN
* Must be at least 18 years old
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy for this primary breast cancer
* At least 7 days since prior tamoxifen or raloxifene as a preventive agent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carlos L. Arteaga
Professor of Medicine and Cancer Biology, Associate Director of Clinical Research, Director VICC Breast Program, Medical Oncologist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carlos L. Arteaga, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama, Birmingham
Birmingham, Alabama, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Meharry Medical College
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VU-VICC-BRE-0222
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-020448
Identifier Type: -
Identifier Source: secondary_id
VICC BRE 0222
Identifier Type: -
Identifier Source: org_study_id