NCT03390894

Brief Summary

This is a multicenter, cohorts study to collect information from patients diagnosed with early-stage invasive breast cancer who have been previously included in a neoadjuvant or adjuvant clinical trial of the GEICAM group. Patients will be included in this study from the moment of completion of the follow-up of the studies of origin and will be followed for approximately 30 years

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
264mo left

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

73 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Jan 2018Jan 2048

First Submitted

Initial submission to the registry

December 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

January 18, 2018

Completed
29 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2047

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2048

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

29 years

First QC Date

December 29, 2017

Last Update Submit

May 13, 2025

Conditions

Keywords

Long-term Follow-UpInvasive Breast Cancer Early StagesPrevious Neoadjuvant treatmentPrevious Adjuvant treatment

Outcome Measures

Primary Outcomes (2)

  • Event Free Survival (EvFS) in neoadjuvant studies.

    The EvFS, is defined as the time from the randomization of the patients in the studies of origin, to the date of one of the following events: * Disease progression during neoadjuvant treatment. * Disease relapse (local, regional or distant) after curative surgery. * Second primary tumors * Death due to any cause.

    Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.

  • Disease Free Survival (DFS) in adjuvant studies.

    DFS is defined as the time from the date of randomization of patients in the studies of origin, to the date of one of the following events: * Disease relapse (local, regional or distant) after curative surgery. * Second primary tumors * Death due to any cause.

    Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.

Secondary Outcomes (1)

  • Overall Survival (OS).

    Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with invasive breast cancer (early stages) included in neoadjuvant and adjuvant clinical trials with GEICAM's participation.

You may qualify if:

  • Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected.
  • Patients whose death or contact loss has not been previously collected in the databases of the original studies.

You may not qualify if:

  • Patient who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (73)

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

NOT YET RECRUITING

Hospital San Agustín Avilés

Avilés, Principality of Asturias, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

NOT YET RECRUITING

Centro Oncológico de Galicia

A Coruña, Spain

RECRUITING

Complejo Hospitalario A Coruña

A Coruña, Spain

RECRUITING

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

RECRUITING

Hospital General Universitario de Alicante

Alicante, Spain

RECRUITING

Hospital General Universitario de Elche

Alicante, Spain

RECRUITING

Hospital General Universitario de Elda

Alicante, Spain

RECRUITING

Hospital Virgen De Los Lirios

Alicante, Spain

RECRUITING

Hospital Infanta Cristina

Badajoz, Spain

RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

RECRUITING

Consorci Sanitari de Terrassa

Barcelona, Spain

RECRUITING

Hospital Clinic i Provincial

Barcelona, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Universitario Mutua Terrassa

Barcelona, Spain

RECRUITING

Instituto Catalán Oncología Barcelona Hospital Duran I Reynalds

Barcelona, Spain

RECRUITING

Hospital Universitario de Basurto

Bilbao, Spain

RECRUITING

Hospital Universitario de Burgos

Burgos, Spain

RECRUITING

Complejo Especialidades de Jerez de la Frontera

Cadiz, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Spain

RECRUITING

Complejo Hospitalario de Castellón

Castelló, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, Spain

RECRUITING

Hospital Virgen De La Luz

Cuenca, Spain

RECRUITING

Hospital Universitario de Cruces

Donostia / San Sebastian, Spain

RECRUITING

Hospital Universitario Donostia

Donostia / San Sebastian, Spain

RECRUITING

Onkologikoa

Donostia / San Sebastian, Spain

RECRUITING

Instituto Catalán de Oncología Gerona Hospital Dr. Josep Trueta

Girona, Spain

RECRUITING

Hospital Universitario San Cecilio

Granada, Spain

RECRUITING

Hospital Universitario Virgen De Las Nieves

Granada, Spain

RECRUITING

Hospital Universitario de Guadalajara

Guadalajara, Spain

RECRUITING

Complejo Hospitalario de Especialidades Juan Ramón Jiménez

Huelva, Spain

RECRUITING

Complejo Hospitalario de Jaén

Jaén, Spain

RECRUITING

Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín

Las Palmas de Gran Canaria, Spain

NOT YET RECRUITING

Hospital de León

León, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Spain

RECRUITING

Hopsital Clínico San Carlos

Madrid, Spain

NOT YET RECRUITING

Hospital de Mostoles

Madrid, Spain

RECRUITING

Hospital general Universitario Gregorio Marañón

Madrid, Spain

RECRUITING

Hospital Madrid Montepricipe

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario Fuenlabrada

Madrid, Spain

RECRUITING

Hospital Universitario Fundación Alcorcón

Madrid, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

RECRUITING

Hospital Universitario Severo Ochoa

Madrid, Spain

RECRUITING

MD Anderson Cancer Center

Madrid, Spain

NOT YET RECRUITING

ALTHAIA Xarxa Asistencial Universitària Manresa

Manresa, Spain

RECRUITING

Hospital Regional de Málaga Carlos Haya

Málaga, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital General Universitario José María Morales Meseguer

Murcia, Spain

RECRUITING

Hospital santa María Naí

Ourense, Spain

RECRUITING

Complejo Hospitalario de Palencia

Palencia, Spain

NOT YET RECRUITING

Hospital Álvaro Cunqueiro

Pontevedra, Spain

RECRUITING

Corporación Sanitaria Parc Taulí

Sabadell, Spain

RECRUITING

Hospital Universitario de Salamanca

Salamanca, Spain

RECRUITING

Hospital Nuestra Señora De La Candelaria

Santa Cruz de Tenerife, Spain

NOT YET RECRUITING

Hospital Universitario de Valme

Seville, Spain

RECRUITING

Hospital Universitario Sant Joan De Reus

Tarragona, Spain

RECRUITING

Hospital Virgen de la Salud

Toledo, Spain

RECRUITING

Fundación Instituto Valenciano de Oncología

Valencia, Spain

RECRUITING

Hospital Arnau Vilanova

Valencia, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital de Sagunto

Valencia, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Hospital Universitari i Politécnic La Fe

Valencia, Spain

RECRUITING

Hospital Universitario Dr. Peset Aleixandre

Valencia, Spain

RECRUITING

Hospital de Txagorritxu

Vitoria-Gasteiz, Spain

RECRUITING

Hospital Clínico Universitario de Zaragoza Lozano Blesa

Zaragoza, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

RECRUITING

Related Links

Study Officials

  • Study Director

    Complejo Hospitalario de Especialidades Virgen de la Victoria

    STUDY DIRECTOR
  • Study Director

    Hospital General Universitario Gregorio Marañón

    STUDY DIRECTOR

Central Study Contacts

Study Project Manager

CONTACT

Start-Up Unit Manager

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2017

First Posted

January 4, 2018

Study Start

January 18, 2018

Primary Completion (Estimated)

January 1, 2047

Study Completion (Estimated)

January 1, 2048

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations