Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2026-01-01 @ 12:25 PM
Study NCT ID:
NCT05184257
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2021-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zoladex® 10.8 BC RWS
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': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with serum E2 suppression at 12 weeks (±4 weeks). Serum E2 suppression is defined as an E2 value below the upper limit of the menopausal reference range', 'timeFrame': 'serum E2 suppression at 12 weeks (±4 weeks) after Zoladex® treatment', 'description': 'To assess the E2 suppressive effect of Zoladex® 10.8 mg is non-inferior to Zoladex® 3.6 mg at 12th week for the treatment of patients with premenopausal and perimenopausal breast cancer.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with serum E2 suppression at 24 weeks (±4 weeks). Serum E2 suppression was defined as an E2 value below the upper limit of the menopausal reference range', 'timeFrame': 'serum E2 suppression at 24 weeks (±4 weeks) after Zoladex®', 'description': 'To assess the E2 suppressive effect of Zoladex® 10.8 mg and Zoladex® 3.6 mg at 24th week for the treatment of patients with premenopausal and perimenopausal breast cancer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40814439', 'type': 'DERIVED', 'citation': 'Wang Y, Wang X, Wu J, Liu H, Zhao J, Huang J, Liu J, Gong Y, Wang H, Yang H, Zou G, Ouyang Q, Jiang G, Liu H, Ni S, Xu B, Yu J. Real-world effectiveness of goserelin 10.8-mg compared to goserelin 3.6-mg in premenopausal and perimenopausal Chinese patients with hormone receptor positive breast cancer: a cohort study. J Natl Cancer Cent. 2025 May 20;5(4):392-401. doi: 10.1016/j.jncc.2025.02.006. eCollection 2025 Aug.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D8664R00002&attachmentIdentifier=45ff70bd-03ba-4deb-bd28-0891932e706f&fileName=D8664R00002-redacted_CSR_synopsis.pdf&versionIdentifier=', 'label': 'CSR Synopsis\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, retrospective-prospective, observational, active-control, non-inferiority, real world study using hospital medical record data, with objectives to evaluate E2 suppressive effect of Zoladex® 10.8 mg is non-inferior to Zoladex® 3.6 mg. Eligible breast cancer patients who received Zoladex® from January 1st, 2015 till December 31st, 2021(including December 31st, 2021) will be identified and included for retrospective data collection and analyses in this study. And prospective data will be monthly collected of eligible patients receiving Zoladex® after January 1st, 2022 (including January 1st, 2022) until approximately 1000 patients being included in this study for analysis. (If site has specific identification of retrospective data and prospective data, it will be subject to the requirement of site). The first date of the presence of Zoladex® treatment or prescription record for breast cancer during the study period will be considered the index date for patients. According to the Zoladex® treatment at the index date, patients will be categorized into two cohorts: Zoladex® 10.8 mg or Zoladex® 3.6 mg.\n\nAbout 10-15 hospitals will be included in this study. To be considered, the hospitals need to have relatively large number of eligible patients, geographic representativeness and willingness to participate in this study. Approximately 1000 eligible patients from selected hospitals during the study period will be included and matched with propensity scores. It is expected that at least 150 matched patients in each of the two cohorts will eventually be included in the primary endpoint analysis. The final subject number will be based on the actual situation of the study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with premenopausal and perimenopausal breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Diagnosed with primary breast cancer\n* Female, ≥18 years old (at index date)\n* HR positive\n* Receive Zoladex® 10.8 mg or Zoladex® 3.6 mg treatment\n* Premenopausal status prior to the treatment of Zoladex®. Baseline premenopausal status will be confirmed if the patient's last E2 measurement within 180 days prior to the index date indicated premenopausal status or there was a recorded menstrual history within 180 days prior to the index date\n* At least one actual or expected E2 testing measurement within 8-28 weeks of the index date Exclusion Criteria\n* Patients received concurrent treatments that may affect E2 testing results"}, 'identificationModule': {'nctId': 'NCT05184257', 'briefTitle': 'Zoladex® 10.8 BC RWS', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'The Effectiveness of Zoladex® 10.8 mg Compared to Zoladex® 3.6mg in the Treatment of Premenopausal and Perimenopausal Hormone Receptor Positive Breast Cancer: A Real-World Study', 'orgStudyIdInfo': {'id': 'D8664R00002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Drugs', 'description': 'The study drug is Zoladex® 10.8 mg. The maximum observation time window for effectiveness analysis is 28 (24+4) weeks.'}, {'label': 'Comparison Drugs', 'description': 'The comparison drug is Zoladex® 3.6 mg. The maximum observation time window for effectiveness analysis is 28 (24+4) weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '410013', 'city': 'Changsha', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chengdu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Guangan', 'country': 'China', 'facility': 'Research Site'}, {'city': 'Guangyuan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.44201, 'lon': 105.823}}, {'zip': '510060', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '250117', 'city': 'Jinan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Nantong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '215006', 'city': 'Suzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Suzhou', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Taiyuan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '300060', 'city': 'Tianjin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Xining', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.62554, 'lon': 101.75739}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}