Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 6:17 AM
Study NCT ID:
NCT06378294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)
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': 'D008408', 'term': 'Mastectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 and 5 years', 'description': 'recurrence in the ipsilateral breast/thoracic wall, regional recurrence, distant recurrence or death'}, {'measure': 'Axillary recurrence rate', 'timeFrame': '3 and 5 years', 'description': 'recurrence rate in the ipsilateral axillary lymph nodes'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'any cause of death as event'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['axillary radiotherapy', 'mastectomy', 'sentinel lymph node biopsy'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '28898379', 'type': 'RESULT', 'citation': 'Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA. 2017 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.'}, {'pmid': '36383926', 'type': 'RESULT', 'citation': 'Bartels SAL, Donker M, Poncet C, Sauve N, Straver ME, van de Velde CJH, Mansel RE, Blanken C, Orzalesi L, Klinkenbijl JHG, van der Mijle HCJ, Nieuwenhuijzen GAP, Veltkamp SC, van Dalen T, Marinelli A, Rijna H, Snoj M, Bundred NJ, Merkus JWS, Belkacemi Y, Petignat P, Schinagl DAX, Coens C, van Tienhoven G, van Duijnhoven F, Rutgers EJT. Radiotherapy or Surgery of the Axilla After a Positive Sentinel Node in Breast Cancer: 10-Year Results of the Randomized Controlled EORTC 10981-22023 AMAROS Trial. J Clin Oncol. 2023 Apr 20;41(12):2159-2165. doi: 10.1200/JCO.22.01565. Epub 2022 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'Sentinel lymph node biopsy (SLNB) is the standard procedure to stage the axilla in clinically node-negative invasive breast cancer (IBC) patients undergoing upfront surgery.\n\nThe ACOSOG-Z0011 and the AMAROS trial demonstrated that SLNB with or without radiotherapy provided equivalent local control and survival to axillary lymph node dissection (ALND) in early-stage breast cancer patients with 1 or 2 positive SLNs. However, the ACOSOG-Z0011 trial did not included patients treated with mastectomy, and the AMAROS trial only included 17% of mastectomy patients.\n\nThe investigators conduct an observational cohort study of early stage breast cancer patients receiving upfront mastectomy with 1 or 2 macrometastases after SLNB. The study aim to demonstrate a 5-year disease-free survival of not less than 80% when ALND is omitted and replaced by axillary radiotherapy, and determine the axillary recurrence rate.', 'detailedDescription': 'This is a multi-center, prospective study with an estimated sample size of 60 early-stage IBC patients.\n\nClinically node-negative T1-2 IBC patients undergoing mastectomy with up to 2 macrometases after SLNB will be informed about this study.\n\nPatients will be checked with annual mammography and clinical examination. The axilla will be checked with ultrasound at 3 and 5 years of the surgery.\n\nAfter surgery, patients will receive axillary radiotherapy, but no ALND, and adjuvant systemic treatment based on international guidelines.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Early-stage invasive breast cancer patients receiving upfront mastectomy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with T1-2 primary invasive breast cancer\n* No suspicion of lymph node involvement prior to sentinel lymph node biopsy\n* Patients undergoing upfront mastectomy\n* Macrometastasis in not more than 2 lymph nodes at sentinel lymph node biopsy\n* Patients treated with adjuvant axillary radiotherapy\n\nExclusion Criteria:\n\n* Prior history of invasive breast cancer\n* Medical contraindication for radiotherapy\n* Medical contraindication for adjuvant systemic treatment\n* Planned neoadjuvant systemic treatment\n* Distant metastasis at initial diagnosis\n* Inability to absorb or understand the meaning of the study information'}, 'identificationModule': {'nctId': 'NCT06378294', 'acronym': 'MACMA', 'briefTitle': 'Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital A Coruña'}, 'officialTitle': 'Locoregional Control With Radiotherapy of cT1-2N0 Invasive Breast Cancer Patients With MACrometastases in the Sentinel Node Treated With MAstectomy: a Multi-center Observational Study', 'orgStudyIdInfo': {'id': 'UHACoruna'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mastectomy patients', 'description': 'clinically node-negative T1-2 invasive breast cancer patients treated with upfront mastectomy', 'interventionNames': ['Procedure: Mastectomy']}], 'interventions': [{'name': 'Mastectomy', 'type': 'PROCEDURE', 'otherNames': ['Axillary radiotherapy without axillary lymph node dissection'], 'description': 'Adjuvant postmastectomy radiotherapy', 'armGroupLabels': ['Mastectomy patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15402', 'city': 'Ferrol', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario Ferrol', 'geoPoint': {'lat': 43.48451, 'lon': -8.23293}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '36214', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Universitario Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Universitario Lugo', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Hospital Universitario Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '36071', 'city': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Universitario Pontevedra', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}], 'overallOfficials': [{'name': 'ALBERTO BOUZÓN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPITAL UNIVERSITARIO A CORUÑA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Results will be published by the investigators in academic journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital A Coruña', 'class': 'OTHER'}, 'collaborators': [{'name': 'Complejo Hospitalario Universitario de Pontevedra', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario Universitario de Vigo', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario Universitario de Santiago', 'class': 'OTHER'}, {'name': 'Hospital Universitario Lucus Augusti', 'class': 'OTHER'}, {'name': 'Complexo Hospitalario de Ourense', 'class': 'OTHER'}, {'name': 'Hospital Arquitecto Marcide', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, M.D., Ph.D.', 'investigatorFullName': 'Alberto Bouzon', 'investigatorAffiliation': 'University Hospital A Coruña'}}}}