Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-02-24 @ 4:15 PM
Study NCT ID:
NCT00535418
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2007-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2007-09-24', 'studyFirstSubmitQcDate': '2007-09-25', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Breast cancer', 'neoadjuvant treatment', 'treatment duration', 'Primary hormone receptor positive', 'breast cancer in postmenopausal women'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '18302747', 'type': 'DERIVED', 'citation': 'Krainick-Strobel UE, Lichtenegger W, Wallwiener D, Tulusan AH, Janicke F, Bastert G, Kiesel L, Wackwitz B, Paepke S. Neoadjuvant letrozole in postmenopausal estrogen and/or progesterone receptor positive breast cancer: a phase IIb/III trial to investigate optimal duration of preoperative endocrine therapy. BMC Cancer. 2008 Feb 26;8:62. doi: 10.1186/1471-2407-8-62.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Female Breast Cancer patients with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive (Clinical Stage \\*T2, T3, T4a,b,c, N0, M0)\n2. Patients after menopause\n3. Tumor measurable by clinical examination, mammography and ultrasound\n4. Adequate bone marrow, renal and hepatic function\n5. A life expectancy of at least 6 months.\n\nExclusion criteria:\n\n1. Prior treatment with aromatase inhibitors or antiestrogens.\n2. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing´s Syndrome, Addison´s disease (treated or untreated), Patients with unstable angina, uncontrolled cardiac disease (e.g. Class II or IV New York Heart Association's Functional Classification).\n3. Patients with tumors in both breasts, evidence of inflammatory breast cancer or distant metastasis\n4. Patients who are eligible for breast conserving surgery.\n5. Concomitant anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (BRM's), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. Patients who have received HRT will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.\n\nOther protocol defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00535418', 'briefTitle': 'Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Pre-operative Hormone Therapy for Postmenopausal Women With ER and/or PgR Positive Breast Cancer: An Uncontrolled Phase IIb/III Trial to Assess Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers', 'orgStudyIdInfo': {'id': 'CFEM345EDE01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole', 'interventionNames': ['Drug: Letrozole']}], 'interventions': [{'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['FEM345'], 'armGroupLabels': ['Letrozole']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}