Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT01402193
Status:
UNKNOWN
Last Update Posted:
2014-06-25
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Arimidex and Radiotherapy Sequencing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003966', 'term': 'Camurati-Engelmann Syndrome'}], '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': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'D011878', 'term': 'Radiotherapy'}], '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'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2014-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of TGF-β1', 'timeFrame': 'First analysis will occur 1 year after first subject enrolled', 'description': 'To compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.'}], 'secondaryOutcomes': [{'measure': 'Acute skin reaction', 'timeFrame': 'First analysis will occur 1 year after first subject enrolled', 'description': 'Acute skin reaction occurrence rate defined by the occurrence of grade II or above acute skin reaction in patients with concurrent or sequential arimidex with radiotherapy.'}, {'measure': 'Other serum inflammatory cytokine', 'timeFrame': 'First analysis will occur 1 year after first subject enrolled', 'description': 'Pre-and post-radiotherapy other serum inflammatory cytokine'}, {'measure': 'Cosmetic outcomes', 'timeFrame': 'First analysis will occur 1 year after first subject enrolled', 'description': 'Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.'}, {'measure': 'Lung toxicity', 'timeFrame': 'First analysis will occur 1 year after first subject enrolled', 'description': 'Occurrence of grade II or higher radiation-induced lung toxicity.'}, {'measure': 'Local-regional recurrence', 'timeFrame': 'First analysis will occur 1 year after first subject enrolled', 'description': 'Local-regional recurrence within two arms.'}, {'measure': 'Correlation between TGF-β1 Change and Clinical Outcomes', 'timeFrame': 'First analysis will occur 1 year after first subject enrolled', 'description': 'The correlation between TGF-β1 change and clinical outcomes will be explored.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Timing of Radiotherapy', 'TGF-beta1'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent\n* Pathological confirmation of breast cancer\n* ER(+) and/or PR(+).\n* Post-menopausal woman\n* Age≤70 years old\n* Breast conservative surgery with axillary dissection or staging by either sentinel nodes biopsy or axillary sampling\n* Post-mastectomy patients with T1-T2 and N1-N3, or T3-T4 with any N Negative surgical margins\n* Karnofsky≥70\n* Laboratory criteria:\n\n * PLT≥100\\*109/L\n * WBC≥4000/mm3\n * HGB≥10g/dl\n * ALT and AST\\<2\\*ULN\n* No presence of metastatic disease\n* No other malignant tumour\n\nExclusion Criteria:\n\n* Presence of metastatic disease.\n* T1, T2, N0 with mastectomy\n* Non-infiltrative breast carcinoma underwent mastectomy\n* Other malignant tumor (concurrent or previous).\n* Positive surgical margins.\n* Patients with demonstrated hypersensitivity to Arimidex or any excipient.\n* Patients with severe renal impairment (creatinine clearance less than 20 ml/min).\n* Patients with moderate or severe hepatic disease.\n* Oestrogen-containing therapies should not be co-administered with Arimidex as they would negate its pharmacological action.\n* Not able or willing to sign informed consent\n* Autoimmune diseases including scleroderma, systemic lupus erythematosus and so on'}, 'identificationModule': {'nctId': 'NCT01402193', 'briefTitle': 'Study of Arimidex and Radiotherapy Sequencing', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer', 'orgStudyIdInfo': {'id': 'BR-RT-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Arm', 'description': 'Investigational treatment: Arimidex commenced before and continued during radiotherapy.\n\nInterventions:\n\nDrug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy', 'interventionNames': ['Drug: Pre-radiotherapy commencement of Arimidex', 'Radiation: Radiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Arm', 'description': 'Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy\n\nInterventions:\n\nRadiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex', 'interventionNames': ['Drug: Post radiotherapy commencement of Arimidex', 'Radiation: Radiotherapy']}], 'interventions': [{'name': 'Pre-radiotherapy commencement of Arimidex', 'type': 'DRUG', 'otherNames': ['Anastrozole'], 'description': 'Arimidex:1mg P.O. daily will be prescribed for 8 weeks in post-mastectomy patients and 9 weeks in BCT patients within the study period. Arimidex starts 3 weeks before adjuvant radiotherapy and throughout the course of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.', 'armGroupLabels': ['Study Arm']}, {'name': 'Post radiotherapy commencement of Arimidex', 'type': 'DRUG', 'otherNames': ['Anastrozole'], 'description': 'Arimidex：1mg P.O. daily will be prescribed at 2 weeks after the end of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.', 'armGroupLabels': ['Control Arm']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['RT, Radiation Therapy'], 'description': 'Radiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery', 'armGroupLabels': ['Study Arm']}, {'name': 'Radiotherapy', 'type': 'RADIATION', 'otherNames': ['RT, Radiation Therapy'], 'description': 'Radiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayi Chen, MD', 'role': 'CONTACT', 'phone': '862164175590', 'phoneExt': '6602'}, {'name': 'Jiayi Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiayi Chen, MD', 'role': 'CONTACT', 'phone': '862164175590', 'phoneExt': '6602'}], 'overallOfficials': [{'name': 'Jiayi Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Department of Radiation Oncology, Fudan University Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Vice Chairman of Department of Radiation Oncology', 'investigatorFullName': 'Jiayi Chen', 'investigatorAffiliation': 'Fudan University'}}}}