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ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

NCT04889924 · Hospital Universitari de Bellvitge
In plain English

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Official title
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
About this study
A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 820 patients (410 patients in neoadjuvant chemotherapy and 410 in neoadjuvant hormone therapy), over 5 years. Patients will be stratified and analyzed independently according to the neoadjuvant treatment regimen, whether chemotherapy (CT) +/- hormonal therapy (HT). A pilot phase of the study was carried out with the first 200 patients (Until 1 May 2023), and an interim analysis will also be performed with these first 200 patients.
Eligibility criteria
Inclusion Criteria: * T1-T4 N0/ T0-T4 N1 at diagnosis and subsidiary of neoadjuvant treatment * Post-CT SLN with ≤2 macrometastasis/micrometastasis or ITCs * Post-CT axillary response by ultrasound or MRI * Complete at least 70% of neoadjuvant chemotherapy and 6 months of endocrine treatment. Exclusion Criteria: * cN2 * ypN0 * History of breast surgery for ipsilateral cancer in the last 10 years * History of other cancer in the last 5 years, except squamous carcinoma of the skin.
Study design
Enrollment target: 820 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-06-11
Estimated completion: 2028-12-31
Last updated: 2026-05-19
Interventions
Radiation: Axillary RadiotherapyProcedure: Lymphadenectomy
Primary outcomes
  • Disease-free survival (From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years)
Sponsor
Hospital Universitari de Bellvitge · other
Contacts & investigators
ContactAmparo Garcia-Tejedor, MDPhD · contact · agarciat@bellvitgehospital.cat · 34 + 932607695
InvestigatorMaria Laplana, MDPhD · principal_investigator, Hospital Clínico y Provincial de Barcelona
InvestigatorAmparo Garcia-Tejedor, MDPhD · principal_investigator, Hospital Universitari de Bellvitge
All locations (60)
GenesisCare MaterRecruiting
Sydney, New South Wales, Australia
GenesisCare North ShoreRecruiting
Sydney, New South Wales, Australia
GenesisCare Frenchs ForestRecruiting
Sydney, New South Wales, Australia
GenesisCare NorwestRecruiting
Sydney, New South Wales, Australia
GenesisCare HurstvilleRecruiting
Sydney, New South Wales, Australia
GenesisCare CampbelltownRecruiting
Sydney, New South Wales, Australia
Hospital Universitari Germans Trias i PujolRecruiting
Badalona, Barcelona, Spain
Instituto Catalán de Oncología de BadalonaRecruiting
Badalona, Barcelona, Spain
Hospital Comarcal Sant Jaume de CalellaRecruiting
Calella, Barcelona, Spain
Hospital General de GranollersNot Yet Recruiting
Granollers, Barcelona, Spain
Consorci Sanitari IntegralRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario de BellvitgeRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Instituto Catalán de Oncología- Hospital Duran i ReynalsRecruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Fundación Althaia ManresaRecruiting
Manresa, Barcelona, Spain
Hospital de MataróRecruiting
Mataró, Barcelona, Spain
Hospital Universitario General de CataluñaNot Yet Recruiting
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario Mútua TerrassaRecruiting
Terrassa, Barcelona, Spain
Consorci Sanitari de TerrassaRecruiting
Terrassa, Barcelona, Spain
Hospital de ViladecansRecruiting
Viladecans, Barcelona, Spain
Hospital Universitario de CrucesRecruiting
Barakaldo, Bizkaia, Spain
Hospital Universitario Galdakao-UsansoloRecruiting
Galdakao, Bizkaia, Spain
Hospital Universitario Puerta del MarNot Yet Recruiting
Cadiz, Cádiz, Spain
Hospital Universitario de DonostiaRecruiting
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Universitario Príncipe de AsturiasRecruiting
Alcalá de Henares, Madrid, Spain
Hospital Universitario Severo OchoaRecruiting
Leganés, Madrid, Spain
Hospital Universitario Puerta De HierroRecruiting
Majadahonda, Madrid, Spain
Hospital Universitario Infanta CristinaRecruiting
Parla, Madrid, Spain
Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
El Palmar, Murcia, Spain
Hospital Ribera PovisaRecruiting
Vigo, Pontevedra, Spain
Hospital Álvaro CunqueiroRecruiting
Vigo, Pontevedra, Spain
Hospital Universitario de CanariasRecruiting
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario Sant Joan de ReusRecruiting
Reus, Tarragona, Spain
Hospital Universitario de A CoruñaRecruiting
A Coruña, Spain
Hospital del MarRecruiting
Barcelona, Spain
Hospital de la Santa Cruz y San PabloRecruiting
Barcelona, Spain
Hospital Clínico y Provincial de BarcelonaRecruiting
Barcelona, Spain
Hospital Universitario de BurgosRecruiting
Burgos, Spain
Hospital Universitario de Gerona Doctor Josep TruetaRecruiting
Girona, Spain
Institut Catalán de Oncología de GironaRecruiting
Girona, Spain
Hospital Universitario Virgen de las NievesRecruiting
Granada, Spain
Hospital Universitario Clínico San CecilioNot Yet Recruiting
Granada, Spain
Hospital General Universitario Gregorio MarañónRecruiting
Madrid, Spain
Hospital Universitario Ramón y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario HM SanchinarroRecruiting
Madrid, Spain
Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta SofíaRecruiting
Madrid, Spain
Hospital Regional Universitario de MálagaRecruiting
Málaga, Spain
Hospital Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Hospital Universitario de NavarraRecruiting
Pamplona, Spain
Hospital MonteceloRecruiting
Pontevedra, Spain
Hospital Universitario Nuestra Señora de CandelariaRecruiting
Santa Cruz de Tenerife, Spain
Hospital General de SegoviaRecruiting
Segovia, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Universitario de Tarragona Juan XXIIIRecruiting
Tarragona, Spain
Instituto Valenciano de OncologíaRecruiting
Valencia, Spain
Hospital Universitario Doctor PesetRecruiting
Valencia, Spain
Hospital Clínico Universitario de ValladolidRecruiting
Valladolid, Spain
Hospital Recoletas Campo Grande de ValladolidRecruiting
Valladolid, Spain
Hospital Universitario de Álava / TxagorritxuRecruiting
Vitoria-Gasteiz, Álava, Spain
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer · TrialPath