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

Primary Purpose

Breast Cancer, Chemotherapy, Sentinel Lymph Node

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Axillary Radiotherapy
Lymphadenectomy
Sponsored by
Hospital Universitari de Bellvitge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T1-T4b N0-1 at diagnosis and subsidiary of neoadjuvant treatment
  • Post-CT SLN with ≤2 macrometastasis
  • If N + pre-neoadjuvant treatment also include micrometastases
  • Post-CT axillary ultrasound, BEDI <4 in all visualized nodes
  • Complete at least 3 months of neoadjuvant chemotherapy and 6 months of endocrine treatment.

Exclusion Criteria:

  • Inflammatory carcinoma or cN2
  • ypN0
  • History of breast surgery for ipsilateral cancer
  • History of other cancer in the last 5 years, except squamous carcinoma of the skin

Sites / Locations

  • Hospital Universitari Germans Trias i PujolRecruiting
  • Instituto Catalán de Oncología de BadalonaRecruiting
  • Hospital Universitario de BellvitgeRecruiting
  • Consorci Sanitari IntegralRecruiting
  • Instituto Catalán de Oncología- Hospital Duran i ReynalsRecruiting
  • Fundación Althaia ManresaRecruiting
  • Hospital Universitario General de Cataluña
  • Hospital Universitario Mútua Terrassa
  • Consorci Sanitari de TerrassaRecruiting
  • Hospital de ViladecansRecruiting
  • Hospital Universitario de CrucesRecruiting
  • Hospital Universitario Galdakao-UsansoloRecruiting
  • Hospital Universitario Puerta del Mar
  • Hospital Universitario de DonostiaRecruiting
  • Hospital Universitario Puerta De HierroRecruiting
  • Hospital Universitario Infanta Cristina
  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting
  • Hospital Ribera Povisa
  • Hospital Álvaro CunqueiroRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital Universitario Sant Joan de Reus
  • Hospital Universitario de A CoruñaRecruiting
  • Hospital del MarRecruiting
  • Hospital Clínico y Provincial de BarcelonaRecruiting
  • Hospital Universitario de BurgosRecruiting
  • Hospital Universitario de Gerona Doctor Josep TruetaRecruiting
  • Institut Catalán de Oncología de GironaRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario Clínico San Cecilio
  • Hospital General Universitario Gregorio MarañónRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta SofíaRecruiting
  • Hospital Regional Universitario de Málaga
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Hospital Universitario de NavarraRecruiting
  • Hospital MonteceloRecruiting
  • Hospital Universitario Nuestra Señora de CandelariaRecruiting
  • Hospital General de SegoviaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Universitario de Tarragona Juan XXIIIRecruiting
  • Instituto Valenciano de OncologíaRecruiting
  • Hospital Clínico Universitario de ValladolidRecruiting
  • Hospital Recoletas Campo Grande de ValladolidRecruiting
  • Hospital Universitario de Álava / TxagorritxuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Axillary radiotherapy without lymphadenectomy

Axillary lymph node dissection

Arm Description

Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy

Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain

Outcomes

Primary Outcome Measures

Lymphedema Incidence
Volume difference between both arms (cm^3) above 10%

Secondary Outcome Measures

Overall survival
to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
Disease-free survival
to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.

Full Information

First Posted
May 5, 2021
Last Updated
October 16, 2023
Sponsor
Hospital Universitari de Bellvitge
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1. Study Identification

Unique Protocol Identification Number
NCT04889924
Brief Title
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer
Acronym
ADARNAT
Official Title
Axillary Lymph Node Dissection Versus Axillary Radiotherapy in Breast Cancer Patients With Positive Sentinel Node After Neoadjuvant Therapy: A Multicenter Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.
Detailed Description
A prospective, randomized, open-label, parallel-assigned, multicenter study. The estimated sample size is 820 patients, over 3 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chemotherapy, Sentinel Lymph Node, Axillary Lymph Nodes Dissection, Radiotherapy Side Effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized, multicenter study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
820 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Axillary radiotherapy without lymphadenectomy
Arm Type
Experimental
Arm Description
Axillary radiotherapy (level I and II) + level III and supraclavicular +/- internal mammary chain without lymphadenectomy
Arm Title
Axillary lymph node dissection
Arm Type
Active Comparator
Arm Description
Axillary lymph node dissection + radiotherapy level III and supraclavicular +/- internal mammary chain
Intervention Type
Radiation
Intervention Name(s)
Axillary Radiotherapy
Intervention Description
Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
Intervention Type
Procedure
Intervention Name(s)
Lymphadenectomy
Intervention Description
Axillary Lymph node dissection
Primary Outcome Measure Information:
Title
Lymphedema Incidence
Description
Volume difference between both arms (cm^3) above 10%
Time Frame
From date of surgery until the date of first lynphedema apparition, assessed up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in overall survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
Time Frame
From date of diagnosis until the date of death from any cause, assessed up to 5 years
Title
Disease-free survival
Description
to assess whether the irradiation of the axilla concerning axillary lymph node dissection is not inferior in disease-free survival, in patients with positive sentinel lymph node (SN) after neoadjuvant systemic treatment.
Time Frame
From date of diagnosis until the date of first documented recurrence or death, wichever came first,assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 3 months 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amparo Garcia-Tejedor, MDPhD
Phone
0034.932607695
Ext
2812
Email
agarciat@bellvitgehospital.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Laplana, MDPhD
Organizational Affiliation
Hospital Clínico y Provincial de Barcelona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amparo Garcia-Tejedor, MDPhD
Organizational Affiliation
Hospital Universitari de Bellvitge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Luna-Tomás
Email
maluna.germanstrias@gencat.cat
First Name & Middle Initial & Last Name & Degree
Miguel Ángel Luna-Tomás
Facility Name
Instituto Catalán de Oncología de Badalona
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Guadalupe Molina
Email
jgmolinao@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Jessica Guadalupe Molina
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amparo Garcia-Tejedor, MDPhD
Phone
660223417
Email
agarciat@bellvitgehospital.cat
First Name & Middle Initial & Last Name & Degree
Amparo Garcia-Tejedor, MDPhD
Facility Name
Consorci Sanitari Integral
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08906
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Buqueras
Email
carmen.buqueras@sanitatintegral.org
First Name & Middle Initial & Last Name & Degree
Carmen Buqueras
Facility Name
Instituto Catalán de Oncología- Hospital Duran i Reynals
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Martínez-Pérez
Email
emperez@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Evelyn Martínez-Pérez
Facility Name
Fundación Althaia Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrés Muñiz-Delgado
Email
AMuniz@CST.CAT
First Name & Middle Initial & Last Name & Degree
Andrés Muñiz-Delgado
First Name & Middle Initial & Last Name & Degree
María Teresa Montes
Facility Name
Hospital Universitario General de Cataluña
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Jurado
Email
jujuseguer@gmail.com
First Name & Middle Initial & Last Name & Degree
Judith Jurado
Facility Name
Hospital Universitario Mútua Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Jesús Díaz-Ruiz
Email
mjdiaz@mutuaterrassa.cat
First Name & Middle Initial & Last Name & Degree
María Jesús Díaz-Ruiz
First Name & Middle Initial & Last Name & Degree
Marta Torras
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Rubio
Email
erubio@cst.cat
First Name & Middle Initial & Last Name & Degree
Esther Rubio
First Name & Middle Initial & Last Name & Degree
Jairo Cortés
Facility Name
Hospital de Viladecans
City
Viladecans
State/Province
Barcelona
ZIP/Postal Code
08840
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Capó
Email
ccapo.hv@gencat.cat
First Name & Middle Initial & Last Name & Degree
Cristina Capó
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Cobos
Email
pcobo@icloud.com
First Name & Middle Initial & Last Name & Degree
Patricia Cobos
Facility Name
Hospital Universitario Galdakao-Usansolo
City
Galdakao
State/Province
Bizkaia
ZIP/Postal Code
48960
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel del Toro
Email
MANUEL.DETOROIGLESIAS@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Manuel del Toro
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
State/Province
Cádiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucía García-Berbel
Email
luciagberbel@gmail.com
First Name & Middle Initial & Last Name & Degree
Lucía García-Berbel
First Name & Middle Initial & Last Name & Degree
Maria Isabel Villanego
Facility Name
Hospital Universitario de Donostia
City
Donostia
State/Province
Gipuzkoa
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Fernández-Calleja
Email
marta.fernandezcalleja@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Marta Fernández-Calleja
First Name & Middle Initial & Last Name & Degree
Elena Guimón
Facility Name
Hospital Universitario Puerta De Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina de la Fuente
Email
cdelafuentealonso@gmail.com
First Name & Middle Initial & Last Name & Degree
Cristina de la Fuente
First Name & Middle Initial & Last Name & Degree
Esther Ramírez
Facility Name
Hospital Universitario Infanta Cristina
City
Parla
State/Province
Madrid
ZIP/Postal Code
28981
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xabier Remirez Arriaga
Email
xabier.remirez@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Xabier Remirez Arriaga
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
El Palmar
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Piñero
Email
pineromadrona@gmail.com
First Name & Middle Initial & Last Name & Degree
Antonio Piñero
Facility Name
Hospital Ribera Povisa
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36211
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ángela Triñares
Email
atrinanes@povisa.es
First Name & Middle Initial & Last Name & Degree
Ángela Triñares
Facility Name
Hospital Álvaro Cunqueiro
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36213
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María José Lamas
Email
macolamas@gmail.com
First Name & Middle Initial & Last Name & Degree
María José Lamas
Facility Name
Hospital Universitario de Canarias
City
La Laguna
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Fernando Otón
Email
lfoton@ull.edu.es
First Name & Middle Initial & Last Name & Degree
Luis Fernando Otón
Facility Name
Hospital Universitario Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredy Castaño
Email
fredy.castano@salutsantjoan.cat
First Name & Middle Initial & Last Name & Degree
Fredy Castaño
First Name & Middle Initial & Last Name & Degree
Coia Jordà
Facility Name
Hospital Universitario de A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra García-Novoa
Email
mag_1406@hotmail.com
First Name & Middle Initial & Last Name & Degree
Alejandra García-Novoa
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Sanz
Email
jsanz@psmar.cat
First Name & Middle Initial & Last Name & Degree
Javier Sanz
First Name & Middle Initial & Last Name & Degree
Marta Jiménez
Facility Name
Hospital Clínico y Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Laplana, MDPhD
Email
maria.laplana.torres@gmail.com
First Name & Middle Initial & Last Name & Degree
Eduard Mensión
First Name & Middle Initial & Last Name & Degree
María Laplana, MDPhD
Facility Name
Hospital Universitario de Burgos
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Ulpiana Pérez-Martínez
Email
yperezma@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
Yolanda Ulpiana Pérez-Martínez
First Name & Middle Initial & Last Name & Degree
Alba González-Castro
Facility Name
Hospital Universitario de Gerona Doctor Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Miguel Alonso
Email
lalonso.girona.ics@gencat.cat
First Name & Middle Initial & Last Name & Degree
Luis Miguel Alonso
Facility Name
Institut Catalán de Oncología de Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arantxa Eraso
Email
aeraso@iconcologia.net
First Name & Middle Initial & Last Name & Degree
Arantxa Eraso
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario Ching
Email
r.ching.lopez@gmail.com
First Name & Middle Initial & Last Name & Degree
Rosario Ching
Facility Name
Hospital Universitario Clínico San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mari Paz López-García
Email
maripaz.lopgar@gmail.com
First Name & Middle Initial & Last Name & Degree
Mari Paz López-García
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Ferreres
Email
karla.ferreres@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Karla Ferreres
First Name & Middle Initial & Last Name & Degree
Ana Calín
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Jesús López-Rodríguez
Email
mariajesus.lopez.rodriguez@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
María Jesús López-Rodríguez
First Name & Middle Initial & Last Name & Degree
Raúl Hernanz
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chelo Sanz
Email
piagaia2000@yahoo.es
First Name & Middle Initial & Last Name & Degree
Chelo Sanz
First Name & Middle Initial & Last Name & Degree
María Colmenero
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Ignacio Sánchez-Méndez
Email
jisanchezmendez@gmail.com
First Name & Middle Initial & Last Name & Degree
José Ignacio Sánchez-Méndez
First Name & Middle Initial & Last Name & Degree
Ana Castaños
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ángel Montero
Email
angel.monteroluis@gmail.com
First Name & Middle Initial & Last Name & Degree
Ángel Montero
Facility Name
Hospital Universitario Infanta Sofía- Fundación de Inv. Biomédica H. Infanta Sofía
City
Madrid
ZIP/Postal Code
28703
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Heras, MD
Email
jherasa@gmail.com
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ismael Herruzo
Email
ismael.herruzo.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Ismael Herruzo
First Name & Middle Initial & Last Name & Degree
Marta Ribeiro
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ángel Calvo
Email
angelcaltu@gmail.com
First Name & Middle Initial & Last Name & Degree
Ángel Calvo
Facility Name
Hospital Universitario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Artieda
Email
cartieds@navarra.es
First Name & Middle Initial & Last Name & Degree
Cristina Artieda
First Name & Middle Initial & Last Name & Degree
Ana Manterola
Facility Name
Hospital Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Fernández
Email
terefez@yahoo.es
First Name & Middle Initial & Last Name & Degree
Teresa Fernández
Facility Name
Hospital Universitario Nuestra Señora de Candelaria
City
Santa Cruz De Tenerife
ZIP/Postal Code
38010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Armijo
Email
anaarmijo0@gmail.com
First Name & Middle Initial & Last Name & Degree
Ana Armijo
Facility Name
Hospital General de Segovia
City
Segovia
ZIP/Postal Code
47002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Isabel Gómez-Calvo
Email
agomezca@saludcastillayleon.es
First Name & Middle Initial & Last Name & Degree
Ana Isabel Gómez-Calvo
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Míguez
Email
carlos.miguez.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Paola Fernández
First Name & Middle Initial & Last Name & Degree
Carlos Míguez
Facility Name
Hospital Universitario de Tarragona Juan XXIII
City
Tarragona
ZIP/Postal Code
43005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judit Aixalà
Email
JAIXALA91@hotmail.com
First Name & Middle Initial & Last Name & Degree
Judit Aixalà
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Fuster
Email
cfuster@fivo.org
First Name & Middle Initial & Last Name & Degree
Carlos Fuster
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana Cortés
Email
scortesperez@hotmail.com
First Name & Middle Initial & Last Name & Degree
Susana Cortés
First Name & Middle Initial & Last Name & Degree
María Luisa del Valle
Facility Name
Hospital Recoletas Campo Grande de Valladolid
City
Valladolid
ZIP/Postal Code
47007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zandra Mileny Soto
Email
zandramileny.soto@gruporecoletas.com
First Name & Middle Initial & Last Name & Degree
Zandra Mileny Soto
First Name & Middle Initial & Last Name & Degree
Rocío Cantalapiedra
Facility Name
Hospital Universitario de Álava / Txagorritxu
City
Vitoria
State/Province
Álava
ZIP/Postal Code
01009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Flaquer
Email
AMANDA.FLAQUERGARCIA@osakidetza.eus
First Name & Middle Initial & Last Name & Degree
Amanda Flaquer
First Name & Middle Initial & Last Name & Degree
Nagore Zeberio

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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