Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 2:06 PM
Study NCT ID:
NCT00247650
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2005-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy
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': 'D000077211', 'term': 'Zoledronic Acid'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D004164', 'term': 'Diphosphonates'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'lastUpdateSubmitDate': '2017-02-28', 'studyFirstSubmitDate': '2005-11-01', 'studyFirstSubmitQcDate': '2005-11-01', 'lastUpdatePostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response at 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Clinical response at 16 weeks'}, {'measure': 'Clinical benefit at 16 weeks'}, {'measure': 'Clinical benefit at 24 weeks'}, {'measure': 'Rate of breast conserving surgery in both arms'}, {'measure': 'Rate of complete pathological response'}, {'measure': 'Biomarkers'}]}, 'conditionsModule': {'keywords': ['neoadjuvant, postmenopausal women, breast cancer, hormonal therapy, bisphosphonate'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38979716', 'type': 'DERIVED', 'citation': 'Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are given before surgery to newly diagnosed post-menopausal women with early breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Postmenopausal women\n* Newly diagnosed with non metastatic breast cancer\n* Candidate for mastectomy or breast-conserving surgery\n\nExclusion Criteria\n\n* Patients with invasive tumors\n* Patients receiving anti-cancer treatment\n* Patients who have undergone surgery\n\nOther protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00247650', 'briefTitle': 'Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Randomized Multi-Center Study Comparing Prolonged Primary Systemic Endocrine Therapy With Letrozole Alone or in Combination With Zoledronic Acid in Early Breast Cancer (NEOadjuvant Study in CANada)', 'orgStudyIdInfo': {'id': 'CZOL446GCA08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zoledronic Acid; Letrozole', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'city': 'Granby', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.40008, 'lon': -72.73243}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Victoriaville', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.05007, 'lon': -71.96579}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis'}}}}