Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT00237133
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2005-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women
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': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2005-10-09', 'studyFirstSubmitQcDate': '2005-10-09', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of Letrozole', 'timeFrame': 'frequency and severity of the clinical adverse events'}]}, 'conditionsModule': {'keywords': ['Breast cancer,', 'Letrozole,', 'Hormonal receptors'], 'conditions': ['Locally Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Postmenopausal women\n2. Primary locally invasive breast cancer\n3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \\> 10% positive malignant epithelial cells.\n4. Post menopausal status\n5. Tumor measurable by clinical examination, mammography and ultrasound\n\nExclusion Criteria:\n\n1. Prior treatment with letrozole or tamoxifen.\n2. Patients with bilateral breast tumors\n3. Patients who are eligible for breast conserving surgery\n4. Evidence of inflammatory breast cancer or distant metastasis.\n5. Other concurrent malignant disease\n6. Concomitant anti-cancer treatments such as chemotherapy\n\nOther protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00237133', 'acronym': 'PREDICT', 'briefTitle': 'Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)', 'orgStudyIdInfo': {'id': 'CFEM345EBR01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole', 'interventionNames': ['Drug: Letrozole']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'description': '1 tablet of Letrozole 2.5 mg orally adminnistered once a day', 'armGroupLabels': ['Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barretos - SP', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Florianopolis - SC', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Fortaleza/CE', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Goiania/GO', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Jau -SP', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Porto Alegre/RS', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Ribeirao - SP', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Santo André', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'Sao Paulo/SP', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}, {'city': 'Vitoria/ES', 'country': 'Brazil', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}