Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 5:44 PM
Study NCT ID:
NCT00768859
Status:
COMPLETED
Last Update Posted:
2012-05-11
First Post:
2008-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study
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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'D016190', 'term': 'Carboplatin'}], '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': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-10', 'studyFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2012-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathologic complete response (pCR) rate at surgery', 'timeFrame': 'at the completion of neo-adjuvant chemotherapy'}], 'secondaryOutcomes': [{'measure': 'To describe disease-free and overall survival', 'timeFrame': 'during routine follow up visits after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'HER2 positive', 'neo-adjuvant', 'trastuzumab', 'paclitaxel', 'carboplatin'], 'conditions': ['Breast Cancer', 'HER2 Positive']}, 'descriptionModule': {'briefSummary': 'To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed infiltrating breast cancer.\n* Stage II or stage III breast cancer.28 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of \\>2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is \\>3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.\n* Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:\n\n * \\>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)\n * \\>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of \\>2.2. or as \\>5 HER2 gene copies per nucleus in CISH analysis.\n\nPatients with a negative or equivocal overall result (FISH test ratio of \\<2.2, \\<6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.\n\n* Age ≥18\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)\n* Adequate bone marrow function (ANC \\>1.0 x 109/l, platelets \\>100 x 109/l)\n* Adequate hepatic function (ALAT, ASAT and bilirubin \\<2 times upper limit of normal)\n* Adequate renal function (creatinine clearance \\>60 ml/min)\n* LVEF ≥50% measured by echocardiography or MUGA\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Signed written informed consent\n\nExclusion Criteria:\n\n* No previous radiation therapy or chemotherapy\n* No other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.\n* No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.\n* No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.\n* No concurrent anti-cancer treatment or another investigational drug"}, 'identificationModule': {'nctId': 'NCT00768859', 'acronym': 'TRAIN', 'briefTitle': 'Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study', 'orgStudyIdInfo': {'id': 'M08TRA'}, 'secondaryIdInfos': [{'id': '2008-000987-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'paclitaxel, trastuzumab and carboplatin', 'interventionNames': ['Drug: paclitaxel, trastuzumab and carboplatin']}], 'interventions': [{'name': 'paclitaxel, trastuzumab and carboplatin', 'type': 'DRUG', 'description': 'paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1800 AM', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medisch Centrum Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'NKI-AVL', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1091 HA', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '2600 AG', 'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Gasthuis', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': '5602 ZA', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '2035 RC', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '2262 BA', 'city': 'Leidschendam', 'country': 'Netherlands', 'facility': 'Medisch Centrum Haaglanden', 'geoPoint': {'lat': 52.08167, 'lon': 4.39281}}, {'zip': '3430 EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Sint Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'G S Sonke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NKI-AvL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'G.S. Sonke, MD PhD', 'oldOrganization': 'NKI-AVL'}}}}