Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-24 @ 10:55 AM
Study NCT ID:
NCT03606616
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2018-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients
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': 142}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2018-07-20', 'studyFirstSubmitQcDate': '2018-07-20', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': '5 years', 'description': 'the time from surgery until death from any cause'}], 'secondaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': '5 years', 'description': 'the time from surgery to death or first documented recurrence of breast cancer'}, {'measure': 'occurrence of surgical morbidities', 'timeFrame': '5 years', 'description': 'edema，limited activity or pain on surgical side upper limb'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACOSOG Z0011', 'Chinese breast cancer', 'sentinel lymph node', 'overall survival', 'disease-free survival'], 'conditions': ['Breast Cancer', 'Sentinel Lymph Node', 'Local Recurrence of Malignant Tumor of Breast']}, 'referencesModule': {'references': [{'pmid': '33879180', 'type': 'RESULT', 'citation': 'Peng Y, Liu M, Li X, Tong F, Cao Y, Liu P, Zhou B, Liu H, Cheng L, Guo J, Xie F, Yang H, Wang S, Wang C, Chen Y, Wang S. Application of the ACOSOG Z0011 criteria to Chinese patients with breast cancer: a prospective study. World J Surg Oncol. 2021 Apr 20;19(1):128. doi: 10.1186/s12957-021-02242-1.'}]}, 'descriptionModule': {'briefSummary': 'In patients undergoing breast-conserving surgery and having positive sentinel lymph nodes (SLNs), the ACOSOG Z0011 trial showed equivalent overall survival(OS) and disease-free survival(DFS) outcomes for patients receiving SLN dissection (SLND) alone and those receiving axillary lymph node dissection (ALND). We conducted a prospective single-arm study to confirm the applicability of the Z0011 criteria to Chinese patients with breast cancer.', 'detailedDescription': 'The American College of Surgeons Oncology Group (ACOSOG) Z0011 trial demonstrated that in clinically node-negative women with T1 or T2 invasive breast cancer, who underwent breast-conserving surgery (BCT) with whole breast irradiation (WBRT), had excellent local control and survival with SLND alone, even if metastases were found in 1 or 2 SLNs. Recently, the long-term follow-up data of the Z0011 study were reported, which demonstrated that the 10-year OS for patients receiving SLND alone was not inferior to that for those receiving ALND.\n\nThis breakthrough result of the Z0011 study led to a change in clinical practice regarding the standard management of axillary lymph nodes in patients with breast cancer.\n\nHowever, these validation data have been generated in Western populations. As the socio-economic profile, life style and culture of Asian are substantially different from those of Western, and genetic backgrounds vary to some extent, it remains unclear whether results similar to those of the Z0011 study could be achieved in a Chinese breast cancer population. In the present study, we prospectively applied the Z0011 eligibility criteria to Chinese patients with clinically node-negative breast cancer undergoing BCT, with planned RT. The purpose of this study is the clinicopathological relevance of the Z0011 findings for Chinese patients with breast cancer, and to verify the feasibility of using the Z0011 criteria to avoid ALND after positive SLN findings.\n\nThis is a prospective single-arm study, enrolled patients meeting Z0011 inclusion criteria and providing consent to receive no additional ALND. Overall survival is the primary end point, disease-free survival and occurrence of surgical morbidities a secondary end point.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'histologically confirmed invasive breast cancer patients, who meeting the critiera of Z0011 inclusion: T1 or T2 tumor,1 or 2 positive sentinel lymph nodes,breast-conserving surgery and whole-breast RT planned is enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed invasive breast cancer T1 or T2 tumor 1 or 2 positive sentinel lymph nodes breast-conserving surgery whole-breast RT planned\n\nExclusion Criteria:\n\n* preoperative therapy 3 or more positive sentinel lymph nodes patients undergoing additional mastectomy due to positive surgical margins'}, 'identificationModule': {'nctId': 'NCT03606616', 'briefTitle': 'Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Prospective Feasibility Study Applying the ACOSOG Z0011 Criteria to Chinese Patients With Early Breast Cancer Undergoing Breast-conserving Surgery', 'orgStudyIdInfo': {'id': 'ACOSOGZ0011CH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ACOSOG Z0011 no further ALND arm', 'description': 'patients meeting the criteria for ACOSOG Z0011 trial inclusion：histologically confirmed invasive breast cancer;clinical T1/T2;breast conserving surgery；1 or 2 positive sentinel lymph nodes; Whole-breast RT planned; no preoperative chemotherapy', 'interventionNames': ['Procedure: no further ALND arm']}], 'interventions': [{'name': 'no further ALND arm', 'type': 'PROCEDURE', 'description': 'Patients meeting the Z0011 inclusion criteria to receive no additional ALND', 'armGroupLabels': ['ACOSOG Z0011 no further ALND arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking university people's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'shu wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Peking University People's Hospital Breast Center", 'investigatorFullName': 'Peng Yuan', 'investigatorAffiliation': "Peking University People's Hospital"}}}}