Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-02 @ 1:15 PM
Study NCT ID:
NCT02049632
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2014-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D061206', 'term': 'Neoplasm Micrometastasis'}], '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': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 805}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2014-01-24', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Breast cancer-specific survival', 'timeFrame': 'Five years'}, {'measure': 'Overall survival', 'timeFrame': 'Five years'}], 'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': 'Five years'}], 'secondaryOutcomes': [{'measure': 'Axillary recurrence rate', 'timeFrame': 'Five years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast cancer', 'Sentinel Node Biopsy', 'Micrometastasis', 'Axillary lymph node dissection'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Sentinel node (SN) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, ALND) in SN-negative patients. SN biopsy alone results in significantly less arm discomfort following the operation.\n\nHowever, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither SN biopsy nor axillary clearance), or without completion ALND after a positive SN biopsy, the importance of ALND is being questioned, even for patients with SN metastases. A large, randomized study (ISBCG23-1) was not able to show any differences in 5-year disease-free survival between patients with SN micrometastases who had undergone ALND and those who had not.\n\nThis Swedish multicenter study will include patients with SN micrometastases. These women will not undergo ALND but will be registered in a study cohort. The patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. Hypothesis: To refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.', 'detailedDescription': 'From April 2017 onwards, only patients operated by mastectomy or those receiving neoadjuvant therapy and having a sentinel node biopsy before its initiation may be recruited into SENOMIC. The inclusion target has been met for those patients operated by breast-conserving therapy, and from now on, these patients will not be included in SENOMIC anymore. Recruitment of the above-mentioned patient selection will continue until 452 patients operated by mastectomy have been enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with clinically node-negative, invasive breast cancer ≤ 5 cm (T1-T2)\n* Histopathology results demonstrate SN micrometastases.\n* Patients who undergo mastectomy (protocol change from April 2017 onwards)\n* The patient must have given verbal and written consent.\n\nExclusion Criteria:\n\n* Preoperatively diagnosed lymph node metastases.\n* Sentinel node metastases \\> 2 mm.\n* Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.\n* History of previous breast cancer.\n* Pregnancy.\n* Bilateral breast cancer where any of the other exclusion criteria applies to either side.\n* Medical contraindication for systemic adjuvant therapy'}, 'identificationModule': {'nctId': 'NCT02049632', 'acronym': 'SENOMIC', 'briefTitle': 'Sentinel Node Biopsy in Breast Cancner: Omission of Axillary Clearance After Micrometastasis', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Survival and Axillary Relapse in Breast Cancer Patients With Sentinel Node Micrometastases Who Have Not Undergone Completion Axillary Clearance - a National Cohort Study', 'orgStudyIdInfo': {'id': 'SENOMIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omission of axillary clearance', 'description': 'No axillary lymph node dissection after sentinel node biopsy and sentinel node micrometastases', 'interventionNames': ['Procedure: Omission of axillary clearance']}], 'interventions': [{'name': 'Omission of axillary clearance', 'type': 'PROCEDURE', 'armGroupLabels': ['Omission of axillary clearance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Helsingborg', 'country': 'Sweden', 'facility': 'Helsingborgs Hospital', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}, {'city': 'Kalmar', 'country': 'Sweden', 'facility': 'Kalmar Hospital', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}, {'city': 'Karlskrona', 'country': 'Sweden', 'facility': 'Karlskrona Hospital', 'geoPoint': {'lat': 56.16156, 'lon': 15.58661}}, {'city': 'Kristianstad', 'country': 'Sweden', 'facility': 'Kristianstad Hospital', 'geoPoint': {'lat': 56.03129, 'lon': 14.15242}}, {'city': 'Lidköping', 'country': 'Sweden', 'facility': 'Lidköping Hospital', 'geoPoint': {'lat': 58.50517, 'lon': 13.15765}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University Hospital', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund and Malmö University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'city': 'Örebro', 'country': 'Sweden', 'facility': 'Örebro University Hospital', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'city': 'Skövde', 'country': 'Sweden', 'facility': 'Skövde Hospital', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Capio St Görans Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds Hospital AB', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Southern General Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'city': 'Sundsvall', 'country': 'Sweden', 'facility': 'Sundsvall Hospital', 'geoPoint': {'lat': 62.39129, 'lon': 17.3063}}, {'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'Uddevalla Hospital', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}, {'city': 'Umeå', 'country': 'Sweden', 'facility': 'Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Akademiska Universitetssjukhuset', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'city': 'Varberg', 'country': 'Sweden', 'facility': 'Varberg Hospital', 'geoPoint': {'lat': 57.10557, 'lon': 12.25078}}, {'city': 'Vaxjo', 'country': 'Sweden', 'facility': 'Växjö Hospital', 'geoPoint': {'lat': 56.87767, 'lon': 14.80906}}, {'city': 'Västerås', 'country': 'Sweden', 'facility': 'Västmanlands Hospital', 'geoPoint': {'lat': 59.61617, 'lon': 16.55276}}, {'city': 'Västervik', 'country': 'Sweden', 'facility': 'Västervik Hospital', 'geoPoint': {'lat': 57.7584, 'lon': 16.63733}}], 'overallOfficials': [{'name': 'Jana M de Boniface, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Jan Frisell, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}, {'name': 'Leif Bergkvist, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uppsala University'}, {'name': 'Yvette Andersson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Västmanlands Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centrallasarettet Västerås', 'class': 'OTHER'}, {'name': 'Uppsala University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jana de Boniface', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}