protocolSection identificationModule nctId: NCT06378294, orgStudyIdInfo id: UHACoruna, briefTitle: Locoregional Control With Radiotherapy of Breast Cancer Patients With MACrometastases Treated With MAstectomy (MACMA), acronym: MACMA, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Hospital A Coruña, class: OTHER, collaborators name: Complejo Hospitalario Universitario de Pontevedra, collaborators name: Complejo Hospitalario Universitario de Vigo, collaborators name: Complejo Hospitalario Universitario de Santiago, collaborators name: Hospital Universitario Lucus Augusti, collaborators name: Complexo Hospitalario de Ourense, 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.The 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.The 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., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Mastectomy, outcomesModule primaryOutcomes measure: Disease-free survival, primaryOutcomes measure: Axillary recurrence rate, secondaryOutcomes measure: Overall survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario Ferrol, status: RECRUITING, city: Ferrol, state: A Coruña, zip: 15402, country: Spain, contacts name: EULALIA VIVES, role: CONTACT, email: Eulalia.Vives.Rodriguez@sergas.es, contacts name: EULALIA VIVES, role: PRINCIPAL_INVESTIGATOR, contacts name: MANUEL DÍAZ, role: SUB_INVESTIGATOR, geoPoint lat: 43.4896, lon: -8.21942, locations facility: Hospital Universitario Santiago de Compostela, status: RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15706, country: Spain, contacts name: MARÍA EFIGENIA ARIAS, role: CONTACT, email: efi.arias@yahoo.com, contacts name: MARÍA EFIGENIA ARIAS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Hospital Universitario Vigo, status: RECRUITING, city: Vigo, state: Pontevedra, zip: 36214, country: Spain, contacts name: GONZALO DE CASTRO, role: CONTACT, email: gonzalo.jose.de.castro.parga@sergas.es, contacts name: GONZALO DE CASTRO, role: PRINCIPAL_INVESTIGATOR, contacts name: GEORGINA FREIRÍA, role: SUB_INVESTIGATOR, geoPoint lat: 42.23282, lon: -8.72264, locations facility: Hospital Universitario A Coruña, status: RECRUITING, city: A Coruña, zip: 15006, country: Spain, contacts name: ALBERTO BOUZÓN, role: CONTACT, phone: +34690103810, email: dr.alberto@aecirujanos.es, contacts name: BENIGNO ACEA, role: CONTACT, phone: +34650482409, email: benigno.acea.nebril@sergas.es, contacts name: MARÍA ALEJANDRA GARCÍA, role: SUB_INVESTIGATOR, contacts name: ALBERTO BOUZÓN, role: PRINCIPAL_INVESTIGATOR, contacts name: BENIGNO ACEA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.37135, lon: -8.396, locations facility: Hospital Universitario Lugo, status: RECRUITING, city: Lugo, zip: 27003, country: Spain, contacts name: LAURA MUÍÑOS, role: CONTACT, email: laura.muiños.ruano@sergas.es, contacts name: LAURA MUÍÑOS, role: PRINCIPAL_INVESTIGATOR, contacts name: PATRICIA VÁZQUEZ, role: SUB_INVESTIGATOR, geoPoint lat: 43.00992, lon: -7.55602, locations facility: Hospital Universitario Ourense, status: RECRUITING, city: Orense, zip: 32005, country: Spain, contacts name: MANUEL GARCÍA, role: CONTACT, email: Manuel.Garcia.Garcia2@sergas.es, contacts name: MANUEL GARCÍA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.33669, lon: -7.86407, locations facility: Hospital Universitario Pontevedra, status: RECRUITING, city: Pontevedra, zip: 36071, country: Spain, contacts name: MARÍA TERESA FERNÁNDEZ, role: CONTACT, email: terefez@yahoo.es, contacts name: MARÍA TERESA FERNÁNDEZ, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.431, lon: -8.64435, hasResults: False