Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT02553850
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2015-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 442}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-29', 'studyFirstSubmitDate': '2015-09-08', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beta C-terminal telopeptide (B-CTx) level', 'timeFrame': '12 months'}, {'measure': 'Treatment response rate', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Number of patients who died due to progression of breast cancer', 'timeFrame': '12 months'}, {'measure': 'Safety: Incidence of adverse events', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This open non-randomized, single-arm, multicenter, observational study is designed to evaluate the correlation between bone turnover markers and the response to treatment in patients with breast cancer and bone metastases. In this observational study, ibandronate (Bondronat) will be prescribed and used in accordance with the standards of care. Data will be collected for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with breast cancer and bone metastases who have been prescribed ibandronate (Bondronat) will be evaluated in the routine oncological setting for 12 months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All criteria in accordance with the Summary of Product Characteristics of Bondronat (ibandronate)\n* Adult patients greater than (\\>) 18 years of age\n* Histologically confirmed breast cancer\n* Confirmed bone metastasis (by bone scintigraphy, X-ray, computed tomography or magnetic resonance imaging)\n* Life expectancy \\>6 months\n* No previous bisphosphonate therapy\n* Patients signed written informed consent form before study start\n\nExclusion Criteria:\n\n* All criteria in accordance with the Summary of Product Characteristics of Bondronat(ibandronate)\n* Hypersensitivity to the active substance or any of the excipients of Bondronat (ibandronate)\n* Hypersensitivity to bisphosphonates'}, 'identificationModule': {'nctId': 'NCT02553850', 'briefTitle': 'An Observational Study in Patients With Breast Cancer and Bone Metastases Receiving Ibandronate (Bondronat)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A SURVEY TO STUDY THE CORRELATION BETWEEN THE SERUM LEVELS OF BONE TURNOVER MARKERS AND THE CLINICAL PICTURE IN PATIENTS WITH BREAST CANCER AND BONE METASTASES RECEIVING IBRADONIC ACID TREATMENT', 'orgStudyIdInfo': {'id': 'ML20416'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ibandronate', 'description': 'Patients receiving ibandronate will be evaluated for bone turnover markers for 12 months. Ibandronate is not an investigational medicinal product (IMP) in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1106', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1125', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1145', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1441', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '9023', 'city': 'Győr', 'country': 'Hungary', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '5700', 'city': 'Gyula', 'country': 'Hungary', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': '7400', 'city': 'Kaposvár', 'country': 'Hungary', 'geoPoint': {'lat': 46.36667, 'lon': 17.8}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '7623', 'city': 'Pécs', 'country': 'Hungary', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '6725', 'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '7100', 'city': 'Szekszárd', 'country': 'Hungary', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '5004', 'city': 'Szolnok', 'country': 'Hungary', 'geoPoint': {'lat': 47.18066, 'lon': 20.19835}}, {'zip': '9700', 'city': 'Szombathely', 'country': 'Hungary', 'geoPoint': {'lat': 47.23088, 'lon': 16.62155}}, {'zip': '2800', 'city': 'Tatabánya', 'country': 'Hungary', 'geoPoint': {'lat': 47.59247, 'lon': 18.38099}}, {'zip': '8200', 'city': 'Veszprém', 'country': 'Hungary', 'geoPoint': {'lat': 47.09327, 'lon': 17.91149}}, {'zip': '8900', 'city': 'Zalaegerszeg-Pozva', 'country': 'Hungary'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}