Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:42 PM
Study NCT ID:
NCT01654367
Status:
UNKNOWN
Last Update Posted:
2012-07-31
First Post:
2012-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Research of Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy to Breast Cancer
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': 'D047072', 'term': 'Aromatase Inhibitors'}], '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': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-26', 'studyFirstSubmitDate': '2012-07-19', 'studyFirstSubmitQcDate': '2012-07-26', 'lastUpdatePostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Recurrence or death', 'timeFrame': '5 years', 'description': 'Recurrence or death'}], 'primaryOutcomes': [{'measure': 'therapeutic assessment', 'timeFrame': '6 months', 'description': 'therapeutic assessment'}], 'secondaryOutcomes': [{'measure': 'Adverse reactions and disease-free survival', 'timeFrame': '2 years', 'description': 'Adverse reactions and disease-free survival'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.', 'detailedDescription': 'The investigators select patients of primary breast cancer whose hormone receptor is positive and accepted postoperative adjuvant aromatase inhibitors for endocrine treatment.Treat them with zoledronic acid 4mg intravenous infusion every six months until the end of the aromatase treatment. Assess the disease-free survival; overall survival; combination of security, as well as the situation of bone loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Karnofsky≥70\n2. Provision of informed consent\n3. Pathological confirmation of breast cancer\n4. Hormone receptor-positive and accept aromatase inhibitors for adjuvant endocrine therapy\n5. Not previously received treatment with bisphosphonate\n6. Laboratory criteria:\n\n PLT≥100\\*109/L WBC≥4000/mm3 HGB≥10g/dl GOT,GPT,ALP≤2\\*ULN TBIL,DBIL,CCr≤1.5\\*ULN\n7. Surgery , radiotherapy and chemotherapy has finished\n\nExclusion Criteria:\n\n1. Pregnant of lactation woman\n2. History of organ transplantation\n3. With mental disease\n4. With severe infection or active gastrointestinal ulcers\n5. With severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes\n6. Disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ)\n7. With heart disease\n8. Experimental drug allergy'}, 'identificationModule': {'nctId': 'NCT01654367', 'acronym': 'esozao', 'briefTitle': 'Research of Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy to Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University'}, 'officialTitle': 'The Effectiveness and Safety of Treating Operable Breast Cancer by the Adjuvant Therapy of Zoledronic Acid and Aromatase Inhibitors and/or Ovarian Function Inhibition', 'orgStudyIdInfo': {'id': 'jzhang2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zoledronic Acid and Aromatase Inhibitors', 'description': 'Zoledronic Acid and Aromatase Inhibitors for Adjuvant Therapy', 'interventionNames': ['Drug: Zoledronic Acid and Aromatase Inhibitors']}], 'interventions': [{'name': 'Zoledronic Acid and Aromatase Inhibitors', 'type': 'DRUG', 'description': 'Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy', 'armGroupLabels': ['Zoledronic Acid and Aromatase Inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'ZHANG SHENG, DOCTOR', 'role': 'CONTACT', 'phone': '86-022-23340123', 'phoneExt': '2901'}, {'name': 'ZHANG SHENG, DORTOR', 'role': 'CONTACT', 'phone': '86-022-23340123', 'phoneExt': '2901'}, {'name': 'ZHANG JIN, PROFESSOR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Jin Zhang, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tianjin Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tianjin Medical University', 'investigatorFullName': 'Zhang jin', 'investigatorAffiliation': 'Tianjin Medical University'}}}}