Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT00130494
Status:
TERMINATED
Last Update Posted:
2019-04-16
First Post:
2005-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077211', 'term': 'Zoledronic Acid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'whyStopped': 'Low recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2002-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2007-10-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-11', 'studyFirstSubmitDate': '2005-08-12', 'studyFirstSubmitQcDate': '2005-08-12', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first bone metastases', 'timeFrame': 'Up to disease progression', 'description': 'The main variable of evaluation is the time until the appearance of first bone metastases.'}], 'secondaryOutcomes': [{'measure': 'Quality of life per treatment arm', 'timeFrame': 'Up to disease progression', 'description': 'Quality of Life (QoL) will be measured with Short Form (SF)-36 questionnaire and Short questionnaire for the evaluation of pain since baseline visit and during all treatment period delivered to the patient before the start of each visit.'}, {'measure': 'The Number of Participants Who Experienced Adverse Events (AE)', 'timeFrame': 'Through study treatment', 'description': 'Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.'}]}, 'conditionsModule': {'keywords': ['Non-symptomatic bone metastases.'], 'conditions': ['Breast Cancer', 'Neoplasm Metastasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.geicam.org', 'label': 'Click here for more information about this study: GEICAM 2001-05'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.', 'detailedDescription': 'Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study.\n\nOnce bone-related symptoms appear, study participation is over. During the study, the following will be assessed:\n\n* quality of life,\n* performance status,\n* pain rating,\n* analgesic administration and\n* adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent.\n* Age \\>= 18 years old.\n* Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.\n* Non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, Central Nervous System (CNS) compression), no need of analgesic chronic administration for bone disease.\n* A maximum of two chemotherapy lines for metastatic disease.\n* A maximum of two hormone therapy lines for metastatic disease.\n* Normal, minimally altered renal function (serum creatinine \\< 1.5 x Upper Normal Limit (UNL)).\n* Normal serum calcium levels.\n* Performance status 0,1 (World Health Organization (WHO)).\n* Negative pregnancy test before study recruitment.\n\nExclusion Criteria:\n\n* Previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization.\n* Metastasis in CNS.\n* History of hypersensitivity to bisphosphonates.\n* Pregnant or lactating women.\n* Third chemotherapy line for metastatic disease.\n* Third hormone therapy line for metastatic disease.\n* Males.'}, 'identificationModule': {'nctId': 'NCT00130494', 'briefTitle': 'Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Spanish Breast Cancer Research Group'}, 'officialTitle': 'Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions', 'orgStudyIdInfo': {'id': 'GEICAM 2001-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Zoledronic acid 4 mg', 'description': 'Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).', 'interventionNames': ['Drug: Zoledronic acid']}, {'type': 'NO_INTERVENTION', 'label': 'Arm B: Observation', 'description': 'Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner).'}], 'interventions': [{'name': 'Zoledronic acid', 'type': 'DRUG', 'otherNames': ['Zometa'], 'armGroupLabels': ['Arm A: Zoledronic acid 4 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28700', 'city': 'San Sebastián de los Reyes', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Spanish Breast Cancer Research Group (GEICAM)', 'geoPoint': {'lat': 40.55555, 'lon': -3.62733}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Clínico Universitario de Valencia'}, {'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spanish Breast Cancer Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}