Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:32 PM
Study NCT ID:
NCT00429104
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2007-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Herceptin and GM-CSF for Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D016178', 'term': 'Granulocyte-Macrophage Colony-Stimulating Factor'}, {'id': 'C081222', 'term': 'sargramostim'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CR_Study_Registration@mdanderson.org', 'phone': '713-792-8754', 'title': 'Naoto Ueno, MD.PhD./Professor', 'organization': 'University of Texas MD Anderson Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 years and 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'HER2+ Metastatic Breast Cancer', 'description': 'Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\\^2 subcutaneously', 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sore Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Muscle Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Sore finger/toes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Red eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Skin Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Itchy hands/feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Tumor Response (Stable Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ Metastatic Breast Cancer', 'description': 'Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\\^2 subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 months', 'description': 'Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.'}, {'type': 'SECONDARY', 'title': 'Duration of Stable Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'HER2+ Metastatic Breast Cancer', 'description': 'Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\\^2 subcutaneously'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '53.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 Years', 'description': 'Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HER2+ Metastatic Breast Cancer', 'description': 'Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\\^2 subcutaneously'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment Period of November 2002 to April 2007, all recruited at University of Texas MD Anderson Cancer Center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'HER2+ Metastatic Breast Cancer', 'description': 'Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\\^2 subcutaneously'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '75'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', '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': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2007-01-29', 'resultsFirstSubmitDate': '2011-03-25', 'studyFirstSubmitQcDate': '2007-01-30', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-25', 'studyFirstPostDateStruct': {'date': '2007-01-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Tumor Response (Stable Disease)', 'timeFrame': '2 months', 'description': 'Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.'}], 'secondaryOutcomes': [{'measure': 'Duration of Stable Disease', 'timeFrame': '6 Years', 'description': 'Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Carcinoma of the Breast', 'HER-2/neu Overexpression', 'Herceptin', 'Trastuzumab', 'GM-CSF', 'Sargramostim', 'Leukine'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'The University of Texas M.D.Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': "Primary Objectives:\n\n1. To determine the patient's tumor response rate that this protocol will produce.\n2. To determine the 1 year progression-free survival that this protocol will produce.\n\nSecondary Objective:\n\n1\\. To determine whether antibody-dependent cell-mediated cytotoxicity (ADCC) is the mechanism of overcoming Herceptin-resistance by use of Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF).", 'detailedDescription': 'GM-CSF stimulates the immune system and may increase the effectiveness of Herceptin.\n\nBefore you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam. This includes blood tests (about 2 tea spoons), and x-rays. Women who are able to have children must have a negative blood or urine pregnancy test.\n\nIf you are found to be eligible to take part in this study, you will receive trastuzumab through a vein (IV) every week until the disease gets worse. GM-CSF will be injected under the skin at least once a day until the white blood cell count is stable. GM-CSF will also continue during the course of study until the disease progresses.\n\nYou will have further evaluation of your disease by computed tomography-CT scan, bone scan, chest X-ray, etc. at 2, 4, 6, 9, 12, 18, and 24 months after the start of treatment. You will have blood tests (about 2 tea spoons) at least twice a week until the appropriate dose of GM-CSF is found. The dose may increase or decrease depending on the blood test.\n\nYou will have blood (about 2 tablespoons) drawn before treatment at the 2nd and 4th month, and if the disease gets worse.\n\nYou will be removed from the study if the disease is progressing or severe side effects occur.\n\nThis is an investigational study. The FDA has approved trastuzumab and GM-CSF, but their use in this study is experimental. A total of 36 patients will take part in this study. All will be enrolled at UT MD Anderson Cancer Center.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histological confirmation of invasive carcinoma of the breast.\n2. HER-2/neu overexpression: 3+ by immunohistochemical staining or Fluorescence in situ hybridization (FISH) (+).\n3. Stage IV breast cancer with measurable disease.\n4. Patient receiving progressive disease after Herceptin plus chemotherapy or Herceptin alone. No more than two Herceptin containing regimens.\n5. Zubrod performance status 0 or 1.\n6. Adequate hematological parameters (White Blood cells-WBC \\> 3,000/mm3, platelet count \\> 100,000/mm3), adequate renal function (serum creatinine \\< 2.0 mg/dl), adequate liver function (total bilirubin, aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT or SGPT) \\< 3 x normal).\n\nExclusion Criteria:\n\n1. Active Brain metastasis.\n2. No measurable disease at the time of registration (e.g. bone only, leptomeningeal disease alone or pleural effusion alone).\n3. More than 2 Herceptin containing regimens in metastatic breast cancer.\n4. Known history of HIV positive.\n5. Chronic active hepatitis or cirrhosis.\n6. Symptomatic pulmonary disease.\n7. Use of steroid of non-steroidal anti-inflammatory analgesic or Cox-2 inhibitor 1 week prior to registration.'}, 'identificationModule': {'nctId': 'NCT00429104', 'briefTitle': 'Herceptin and GM-CSF for Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase II Study of GM-CSF to Overcome Herceptin-Resistant HER-2/Neu-Overexpressing Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'DM01-0100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HER2+ Metastatic Breast Cancer', 'description': 'Herceptin 4 mg/kg IV Over 90 Minutes + GM-CSF 250 mcg/m\\^2 subcutaneously', 'interventionNames': ['Drug: Herceptin', 'Drug: GM-CSF']}], 'interventions': [{'name': 'Herceptin', 'type': 'DRUG', 'otherNames': ['Trastuzumab'], 'description': '4 mg/kg IV Over 90 Minutes', 'armGroupLabels': ['HER2+ Metastatic Breast Cancer']}, {'name': 'GM-CSF', 'type': 'DRUG', 'otherNames': ['Sargramostim', 'Leukine'], 'description': '250 mcg/m\\^2 Subcutaneously', 'armGroupLabels': ['HER2+ Metastatic Breast Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'U.T.M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Naoto Ueno, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}