Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-30 @ 3:37 PM
Study NCT ID:
NCT00633750
Status:
COMPLETED
Last Update Posted:
2012-09-05
First Post:
2008-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Sponsor:
Organization:
Raw JSON
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Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.', 'otherNumAtRisk': 47, 'otherNumAffected': 44, 'seriousNumAtRisk': 47, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Alkaline phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Arthiritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders'}, {'term': 'Infection (without neutropenia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Joint, muscle or bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Mood Changes - depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Mood Changes-anxiety/agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'General disorders'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'SGPT (ALT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Hot flashes/flushes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders'}, {'term': 'High cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulmonary ebmolisim', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Following a pre-treatment core breast biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5-14 days', 'description': 'In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received the study drug and who had available pre- and post-treatment tissue.', 'anticipatedPostingDate': '2010-07'}, {'type': 'SECONDARY', 'title': 'Molecular Profile of Participants Who Are Responsive to Tarceva', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants undergo a post-treatment resection of their tumor.'}], 'classes': [{'title': 'Estrogen receptor positive', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Estrogen receptor negative', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'HER-2 positive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'HER-2 negative', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at 5-14 days', 'description': 'Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = \\> 10% of cell show staining, negative = \\< 10% of cells show staining', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available pre- and post-treatment tissue and who demonstrated a post-treatment decrease in Ki67 levels compared to their pre-treatment levels'}, {'type': 'SECONDARY', 'title': 'Average Post-treatment Plasma Level of Erlotinib Hydrochloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'Following a pre-treatment core biopsy, participants are given Tarceva at a dose of 150 mg/day by mouth for 5-14 days. Within 24 hours of their last dose of Tarceva, participants have their blood drawn and then undergo surgical resection of their tumor.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '7.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After last dose of Tarceva, at 5-14 days, and before surgery', 'description': 'Post-treatment plasma level in µmol/L of erlotinib hydrochloride', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with blood taken within 24 hours of last dose of erlotinib and before surgery'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tarceva', 'description': 'Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment period = 8/28/2002 through 10/16/2007', 'preAssignmentDetails': '54 participants were initially consented for this study. Four were determined to be ineligible. Three participants withdrew from the study before beginning.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tarceva', 'description': 'Tarceva given by mouth at a dose of 150 mg/day for 5-14 days. Participants are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2008-03-11', 'resultsFirstSubmitDate': '2012-05-01', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-02', 'studyFirstPostDateStruct': {'date': '2008-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva', 'timeFrame': '5-14 days', 'description': 'In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.'}], 'secondaryOutcomes': [{'measure': 'Molecular Profile of Participants Who Are Responsive to Tarceva', 'timeFrame': 'at 5-14 days', 'description': 'Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained. Positive = \\> 10% of cell show staining, negative = \\< 10% of cells show staining'}, {'measure': 'Average Post-treatment Plasma Level of Erlotinib Hydrochloride', 'timeFrame': 'After last dose of Tarceva, at 5-14 days, and before surgery', 'description': 'Post-treatment plasma level in µmol/L of erlotinib hydrochloride'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I breast cancer', 'stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.\n\nPURPOSE: This phase II trial is studying how well erlotinib works in treating patients with breast cancer that can be removed by surgery.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* 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.\n* To correlate tumor concentrations of erlotinib hydrochloride with serum levels immediately before surgery.\n\nOUTLINE: This is a multi-center study.\n\nPatients 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.\n\nTumor 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.\n\nPatients are followed within 6 weeks after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma\n\n * Diagnosis may be made by fine needle aspiration cytology or core biopsy\n\n * A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining\n\nExclusion Criteria:\n\n* Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible\\*\n\n * Locally advanced disease includes any of the following:\n\n * Primary tumor ≥ 5 cm (T3)\n * Tumor of any size with direct extension to the chest wall or skin (T4a-c)\n * Inflammatory breast cancer (T4d)\n * Fixed axillary lymph node metastases (N2)\n * 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\n* Measurable residual tumor at the primary site\n\n * Measurable disease is defined as any mass that can be reproducibly measured by physical examination\n* Planning to undergo surgical treatment with either segmental resection or total mastectomy\n* Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer\n* No locally recurrent breast cancer\n* No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* ANC ≥ 1,000/mm\\^3\n* Creatinine ≤ 1.5 times upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 times ULN\n* Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) ≤ 1.5 times ULN\n* Must be at least 18 years old\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No prior chemotherapy for this primary breast cancer\n* At least 7 days since prior tamoxifen or raloxifene as a preventive agent'}, 'identificationModule': {'nctId': 'NCT00633750', 'briefTitle': 'Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer', 'orgStudyIdInfo': {'id': 'VICC BRE 0222'}, 'secondaryIdInfos': [{'id': 'VU-VICC-BRE-0222'}, {'id': 'VU-VICC-020448'}, {'id': 'P50CA098131', 'link': 'https://reporter.nih.gov/quickSearch/P50CA098131', 'type': 'NIH'}, {'id': 'R01CA080195', 'link': 'https://reporter.nih.gov/quickSearch/R01CA080195', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tarceva', 'interventionNames': ['Drug: erlotinib hydrochloride', 'Genetic: TUNEL assay', 'Genetic: protein expression analysis', 'Other: immunohistochemistry staining method', 'Other: laboratory biomarker analysis', 'Other: liquid chromatography', 'Other: mass spectrometry', 'Other: matrix-assisted laser desorption ionization mass spectrometry', 'Procedure: therapeutic conventional surgery']}], 'interventions': [{'name': 'erlotinib hydrochloride', 'type': 'DRUG', 'otherNames': ['OSI-774', 'erlotonib'], 'description': '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.', 'armGroupLabels': ['Tarceva']}, {'name': 'TUNEL assay', 'type': 'GENETIC', 'description': 'Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens', 'armGroupLabels': ['Tarceva']}, {'name': 'protein expression analysis', 'type': 'GENETIC', 'description': 'Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens', 'armGroupLabels': ['Tarceva']}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'description': 'Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens', 'armGroupLabels': ['Tarceva']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Used to assess level of expression of genetic markers in pre-therapy and surgical specimens', 'armGroupLabels': ['Tarceva']}, {'name': 'liquid chromatography', 'type': 'OTHER', 'otherNames': ['(LC/MS)'], 'description': 'Used to determine blood plasma levels of Erlotinib on the day of surgery', 'armGroupLabels': ['Tarceva']}, {'name': 'mass spectrometry', 'type': 'OTHER', 'otherNames': ['(LC/MS)'], 'description': 'Used to determine blood plasma levels of Erlotinib on the day of surgery', 'armGroupLabels': ['Tarceva']}, {'name': 'matrix-assisted laser desorption ionization mass spectrometry', 'type': 'OTHER', 'otherNames': ['MALDI MS'], 'description': 'After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue', 'armGroupLabels': ['Tarceva']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Surgical treatment will occur within 24-hours following completion of therapy.', 'armGroupLabels': ['Tarceva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama, Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '37208', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Meharry Medical College', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Carlos L. Arteaga, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Cancer Biology, Associate Director of Clinical Research, Director VICC Breast Program, Medical Oncologist', 'investigatorFullName': 'Carlos L. Arteaga', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}