Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT00235235
Status:
TERMINATED
Last Update Posted:
2015-12-09
First Post:
2005-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D001706', 'term': 'Biopsy'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'core biopsy, serum, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'Funding terminated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2005-10-06', 'studyFirstSubmitQcDate': '2005-10-06', 'lastUpdatePostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced breast cancer', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'To correlate serum and tumor proteomic profiles with response to commonly used chemotherapies.', 'timeFrame': '36 months'}, {'measure': 'To compare serum and tissue proteomic analyses.', 'timeFrame': '36 months'}, {'measure': 'To compare genomic and proteomic profiles.', 'timeFrame': '36 months'}, {'measure': 'To correlate toxicity and/or response with drug-specific pharmacogenomic parameters.', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.hoosieroncologygroup.org', 'label': 'Hoosier Oncology Group Home Page'}]}, 'descriptionModule': {'briefSummary': 'The proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.', 'detailedDescription': 'OUTLINE: This is a 4 arm, multi-center study.\n\nSample Collection:\n\n* Core Biopsy\n* Serum\n* Urine\n\nTreatment Regimens (Investigator/Patient Discretion):\n\n* Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle\n* Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle\n* Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle\n* Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle\n\nPerformance status \\& Organ Function:\n\nPerformance status and organ function appropriate for chemotherapy in the opinion of the treating investigator according to Good Clinical Practice (GCP).\n\nLife Expectancy: Not specified\n\nHematopoietic: Not specified\n\nHepatic: Not specified\n\nRenal: Not specified\n\nCardiovascular: Not specified\n\nPulmonary: Not specified'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study limited to patients with breast cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.\n* Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.\n* Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.\n* Planned chemotherapy with one of the following regimens:\n\n 1. Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle\n 2. Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle\n 3. Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle\n 4. Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle\n\nExclusion Criteria:\n\n* No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.\n* Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.\n* Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.\n* No breast-feeding.'}, 'identificationModule': {'nctId': 'NCT00235235', 'briefTitle': 'A Correlative Study for Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hoosier Cancer Research Network'}, 'officialTitle': 'Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01', 'orgStudyIdInfo': {'id': 'HOG COE-01'}, 'secondaryIdInfos': [{'id': 'Department of Defense BC030400', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.Gov'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 2 of every 21-day cycle', 'interventionNames': ['Procedure: Biopsy', 'Procedure: Serum Collection', 'Procedure: Urine Collection', 'Drug: Doxorubicin', 'Drug: Cyclophosphamide']}, {'label': 'B', 'description': 'Capecitabine 1000mg/m2 bid days 1-14 of every 21-day cycle', 'interventionNames': ['Procedure: Biopsy', 'Procedure: Serum Collection', 'Procedure: Urine Collection', 'Drug: Capecitabine']}, {'label': 'C', 'description': 'Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle', 'interventionNames': ['Procedure: Biopsy', 'Procedure: Serum Collection', 'Procedure: Urine Collection', 'Drug: Vinorelbine']}, {'label': 'D', 'description': 'Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle', 'interventionNames': ['Procedure: Biopsy', 'Procedure: Serum Collection', 'Procedure: Urine Collection', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'core biopsy', 'armGroupLabels': ['A', 'B', 'C', 'D']}, {'name': 'Serum Collection', 'type': 'PROCEDURE', 'description': 'serum collection', 'armGroupLabels': ['A', 'B', 'C', 'D']}, {'name': 'Urine Collection', 'type': 'PROCEDURE', 'description': 'urine collection', 'armGroupLabels': ['A', 'B', 'C', 'D']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin 60 mg/m2 day 1 of every 21-day cycle', 'armGroupLabels': ['A']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle', 'armGroupLabels': ['A']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Capecitabine 1000 mg/m2 bid days 1-14 of every 21-day cycle', 'armGroupLabels': ['B']}, {'name': 'Vinorelbine', 'type': 'DRUG', 'description': 'Vinorelbine 25mg/m2 days 1, 8, 15 of every 28-day cycle', 'armGroupLabels': ['C']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle', 'armGroupLabels': ['D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47403', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Cancer Care Center of Southern Indiana', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '46815', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Oncology & Hematology, Inc', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46527', 'city': 'Goshen', 'state': 'Indiana', 'country': 'United States', 'facility': 'Center for Cancer Care at Goshen Health System', 'geoPoint': {'lat': 41.58227, 'lon': -85.83444}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46227', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Mary Lou Mayer, M.D.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Regional Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47904', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Arnett Cancer Care', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '47905', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Horizon Oncology Center', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northern Indiana Cancer Research Consortium', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine - Methodist Breast Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto de Enfermedades Neoplasticas (INEN)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Kathy Miller, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoosier Oncology Group, LLC'}, {'name': 'George Sledge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hoosier Oncology Group, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoosier Cancer Research Network', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'Indiana University School of Medicine', 'class': 'OTHER'}, {'name': 'Walther Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, IU School of Medicine', 'investigatorFullName': 'Kathy Miller, MD', 'investigatorAffiliation': 'Hoosier Cancer Research Network'}}}}