Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-28 @ 6:14 AM
Study NCT ID:
NCT00453635
Status:
TERMINATED
Last Update Posted:
2012-03-13
First Post:
2007-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'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': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'whyStopped': 'Due to poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-12', 'studyFirstSubmitDate': '2007-03-28', 'studyFirstSubmitQcDate': '2007-03-28', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression between the two treatment arms', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year'}, {'measure': 'Toxicity profile', 'timeFrame': 'During the time of chemotherpy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cancer', 'Breast cancer', 'First line treatment', 'Docetaxel', 'Carboplatin', 'Herceptin', 'Vinorelbine'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.', 'detailedDescription': 'Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Performance status (WHO) 0-2\n* Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received\n* HER-2 overexpression 2+ or 3+ using IHC or FISH +\n* Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)\n* No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)\n* More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered\n* No prior first line chemotherapy for metastatic disease\n* Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease\n* Paraffin block from the primary tumor available in the research lab\n* Adequate bone marrow function (absolute neutrophil count \\> 1000/mm\\^3, platelet count \\> 100000/mm\\^3, hemoglobin \\> 9 gr/mm\\^3)\n* Adequate liver (Bilirubin \\< 1.5 times upper limit of normal and SGOT/SGPT \\< 2 times upper limit of normal) and renal function (creatinine \\< 2mg/dl)\n* Adequate cardiac function (LVEF \\> 50%)\n* Informed consent\n\nExclusion Criteria:\n\n* Pregnant or nursing\n* Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome\n* Positive pregnancy test\n* Motor or sensory neuropathy \\> grade 1 according to NCIC Τoxicity Criteria\n* Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation\n* History of allergic reaction attributed to docetaxel\n* Psychiatric illness or social situation that would preclude study compliance\n* Other concurrent uncontrolled illness.\n* Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ'}, 'identificationModule': {'nctId': 'NCT00453635', 'briefTitle': 'Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'CT/03.08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)', 'interventionNames': ['Drug: Docetaxel', 'Drug: Carboplatin', 'Drug: Herceptin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Vinorelbine + Herceptin (VHer)', 'interventionNames': ['Drug: Herceptin', 'Drug: Vinorelbine']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel at the dose of 75mg/m\\^2 IV on day 1 every 3 weeks for 6 consecutive cycles', 'armGroupLabels': ['1']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles', 'armGroupLabels': ['1']}, {'name': 'Herceptin', 'type': 'DRUG', 'description': 'Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks', 'armGroupLabels': ['1', '2']}, {'name': 'Vinorelbine', 'type': 'DRUG', 'otherNames': ['Navelbine'], 'description': 'Vinorelbine at the dose of 60mg/m\\^2 per os,weekly', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University Hospital of Crete', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Dep of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"IASO" General Hospital of Athens, 1st Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '401 Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Air Forces Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Marika Iliadis" Hospital of Athens, Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'State General Hospital of Larissa', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Piraeus', 'country': 'Greece', 'facility': '"Metaxa\'s" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': '"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Dimitris Mavroudis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Crete, Dep of Medical Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'D. Mavrudis', 'oldOrganization': 'Hellenic Oncology Research Group'}}}}