Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT00615602
Status:
COMPLETED
Last Update Posted:
2015-03-04
First Post:
2008-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ 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': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D000078224', 'term': 'Lenograstim'}, {'id': 'C455861', 'term': 'pegfilgrastim'}], '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': '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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 489}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-03', 'studyFirstSubmitDate': '2008-02-01', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year disease-free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Recurrence rate', 'timeFrame': 'Relapses by the time of 3-years follow up'}, {'measure': 'Τoxicity profile', 'timeFrame': 'Toxicity assessment on each chemotherapy cycle'}, {'measure': 'Quality of life between the two treatment arms', 'timeFrame': 'Assessment every two cycles'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Early breast cancer', 'Axillary node positive', 'HER2 overexpression', 'Adjuvant chemotherapy', 'Dose dense', 'Docetaxel', 'Trastuzumab', 'FEC'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2', 'detailedDescription': 'Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. Trastuzumab (anti-HER2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing HER2'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma\n* HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive\n* Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.\n* Tumor involvement of at least one axillary lymph node (N0 with HER2/c-neu over expression are also eligible)\n* Absence of any clinical or radiological evidence of local or metastatic disease\n* Premenopausal or postmenopausal women aged 18-75 years old\n* Adequate bone marrow function (absolute neutrophil count \\>1500/mm3, platelet count \\>100.000/mm3, hemoglobin \\>10gr/mm3)\n* Adequate liver (bilirubin \\<1.0 times upper limit of normal and SGOT/SGPT \\<2.5 times upper limit of normal) and renal function (creatinine \\<1.5mg/dl)\n* Adequate cardiac function (LVEF\\>50%). Normal electrocardiogram and absence of significant heart disease\n* Written informed consent\n\nExclusion Criteria:\n\n* Positive pregnancy test.\n* Psychiatric illness or social situation that would preclude study compliance.\n* Other concurrent uncontrolled illness.\n* Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.\n* Previous history of other invasive malignancy other than non-melanomatous skin cancer.'}, 'identificationModule': {'nctId': 'NCT00615602', 'briefTitle': 'Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2', 'orgStudyIdInfo': {'id': 'CT/04.23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'FEC -\\> TXT+H 12m', 'interventionNames': ['Drug: Docetaxel', 'Drug: Trastuzumab', 'Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: 5-fluoruracil', 'Drug: Granulocyte-colony stimulating growth factor']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'FEC -\\> TXT+H 6m', 'interventionNames': ['Drug: Docetaxel', 'Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: 5-fluoruracil', 'Drug: Granulocyte-colony stimulating growth factor', 'Drug: Trastuzumab']}], 'interventions': [{'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['Taxotere'], 'description': 'Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles', 'armGroupLabels': ['1', '2']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': 'Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months', 'armGroupLabels': ['1']}, {'name': 'Epirubicin', 'type': 'DRUG', 'otherNames': ['Farmorubicin'], 'description': 'Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles', 'armGroupLabels': ['1', '2']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Endoxan'], 'description': 'Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks', 'armGroupLabels': ['1', '2']}, {'name': '5-fluoruracil', 'type': 'DRUG', 'otherNames': ['5-FU'], 'description': '5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks', 'armGroupLabels': ['1', '2']}, {'name': 'Granulocyte-colony stimulating growth factor', 'type': 'DRUG', 'otherNames': ['Granocyte', 'Neulasta'], 'description': 'rhG-CSF 5 μg/kg/d on days 3-10 after each cycle', 'armGroupLabels': ['1', '2']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': 'Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months', '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': '"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology', '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': 'Larissa', 'country': 'Greece', 'facility': 'State General Hospital of Larissa, Dep of Medical Oncology', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'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 Mavrudis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Crete'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}