Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-01-25 @ 7:53 PM
Study NCT ID:
NCT00617968
Status:
COMPLETED
Last Update Posted:
2009-09-02
First Post:
2008-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GETNA2 Neoadj. TAX+Femara vs Femara in g I/II 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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-01', 'studyFirstSubmitDate': '2008-02-06', 'studyFirstSubmitQcDate': '2008-02-06', 'lastUpdatePostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of clinical and radiological response evaluated according to RECIST criteria', 'timeFrame': 'During the study conduct'}], 'secondaryOutcomes': [{'measure': 'Rate of histological response', 'timeFrame': 'During the study conduct'}]}, 'conditionsModule': {'conditions': ['Breast Neoplasms']}, 'descriptionModule': {'briefSummary': 'Primarily to evaluate the rates of clinical and radiological response in the 2 groups. Secondarily rate of histological response.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female patients with breast cancer histologically proven by microbiopsy (14G or 16G) enabling confirmation of the diagnosis, and evaluation of the histological prognostic grade, hormonal receptors and HER2 status.\n* Tumor T2 or T3, non-metastasized, non-inflammatory, unilateral\n* Clinically or radiologically measurable lesion greater than 2 cm (ultrasound and/or mammogram)\n* Receptors RE+ and/or RP+ (positive status determined according to the criteria of the investigating centers)\n* HER 2 / neu status of 0, 1+ or 2+ in immunohistochemistry\n* Histological grade I or II\n* Menopausal patients aged greater than or equal to 60 years\n* Patients with ECOG PS greater than or equal to 2\n* Satisfactory hematological, hepatic and renal functions:\n* Hemoglobin greater than or equal to 10 g/dL\n* Platelet count greater than or equal to 100x109/L\n* Polynuclear neutrophil count greater than 1.5x109/L\n* Creatinine less than or equal to ≤ 1.5 ULN\n* AST/ALT less than or equal to 1.5 ULN\n* Alkaline phosphatases less than or equal to 2.5 ULN\n* Patients able to be followed throughout the study\n* Patient's consent obtained.\n\nExclusion Criteria:\n\n* Inflammatory or T4 breast cancer\n* T1 tumor\n* Patients whose tumor is deemed by the doctor to be difficult to evaluate\n* Tumor that is metastatic from the outset (M1) or locally advanced and inoperable from the outset\n* RE and RP receptors negative or unknown\n* HER 2/neu positive at 3 +\n* Non-menopausal patients\n* Surgical biopsy and/or ganglion dissection before neoadjuvant treatment\n* Significant poorly controlled cardiac disorders, such as unstable angina pectoris, poorly controlled heart failure, arrhythmia requiring treatment, or myocardial infarction within the last 3 months\n* Cardiovascular, hepatic, neurological or endocrine disease, or other major systemic disease that makes it difficult to conduct the protocol or to interpret the results\n* Previous history of cancer that occurred within the last 10 years, with the exception of cervical cancers and basocellular skin cancers that were properly treated\n* Allergy to polysorbate 80\n* Hypersensitivity to docetaxel\n* Participation in another clinical trial with one of the study medicinal products during the 30 days prior to entry in the study\n* Patients who are unable to undergo medical monitoring for geographical, social or psychological reasons"}, 'identificationModule': {'nctId': 'NCT00617968', 'briefTitle': 'GETNA2 Neoadj. TAX+Femara vs Femara in g I/II Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Multicenter, Randomized, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Treatment Consisting of Either a Docetaxel - Letrozole Combination or Letrozole Alone in Women Over 60 Years of Age Suffering From Grade I or II Operable Hormone Receptor-positive Breast Tumor.', 'orgStudyIdInfo': {'id': 'XRP6976D_2502'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DOCETAXEL', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Nathalie BILLON', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Nathalie Billon/Study Director', 'oldOrganization': 'sanofi-aventis'}}}}