Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies

May 13, 2025 updated by: Spanish Breast Cancer Research Group

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

One consequence of the improvement in survival rates of certain tumors such as breast cancer is the increase in the number of patients available for long-term follow-up in randomized controlled clinical trials. This long follow-up allows an additional long-term evaluation of the efficacy, as well as of the sequelae related to the treatments that may occur beyond the time of the primary analysis.

The target population of the study are all patients who were included in neoadjuvant and adjuvant clinical trials of GEICAM performed by the goup since 1998 in the medical oncology units of the participating sites, ensuring a follow-up of patients of approximately 30 years. This will allow to describe the long-term evolution of the patients with invasive breast cancer in early stages.

The information obtained will be very useful to professionals involved in the diagnosis, treatment and monitoring of breast cancer, hospital managers, patients with this condition and society in general. This study provides data of great interest for the estimation of long-term disease requirements.

Study Type

Observational

Enrollment (Estimated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • A Coruña, Spain
        • Recruiting
        • Centro Oncologico de Galicia
      • A Coruña, Spain
        • Recruiting
        • Complejo Hospitalario A Coruña
      • Albacete, Spain
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Elche
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Alicante
      • Alicante, Spain
        • Recruiting
        • Hospital General Universitario de Elda
      • Alicante, Spain
        • Recruiting
        • Hospital Virgen de los Lirios
      • Badajoz, Spain
        • Recruiting
        • Hospital Infanta Cristina
      • Badalona, Spain
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic i Provincial
      • Barcelona, Spain
        • Recruiting
        • Consorci Sanitari de Terrassa
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario Mútua Terrassa
      • Barcelona, Spain
        • Recruiting
        • Instituto Catalán Oncología Barcelona Hospital Duran I Reynalds
      • Bilbao, Spain
        • Recruiting
        • Hospital Universitario de Basurto
      • Burgos, Spain
        • Recruiting
        • Hospital Universitario de Burgos
      • Cadiz, Spain
        • Recruiting
        • Complejo Especialidades de Jerez de la Frontera
      • Castelló, Spain
        • Recruiting
        • Complejo Hospitalario de Castellón
      • Cuenca, Spain
        • Recruiting
        • Hospital Virgen de la Luz
      • Cádiz, Spain
        • Recruiting
        • Hospital Universitario Puerta del Mar
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofía
      • Donostia, Spain
        • Recruiting
        • Onkologikoa
      • Donostia, Spain
        • Recruiting
        • Hospital Universitario Donostia
      • Donostia, Spain
        • Recruiting
        • Hospital Universitario de Cruces
      • Gerona, Spain
        • Recruiting
        • Instituto Catalán de Oncología Gerona Hospital Dr. Josep Trueta
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
      • Granada, Spain
        • Recruiting
        • Hospital Universitario San Cecilio
      • Guadalajara, Spain
        • Recruiting
        • Hospital Universitario de Guadalajara
      • Huelva, Spain
        • Recruiting
        • Complejo Hospitalario de Especialidades Juan Ramón Jiménez
      • Jaén, Spain
        • Recruiting
        • Complejo Hospitalario de Jaén
      • León, Spain
        • Recruiting
        • Hospital de Leon
      • Lugo, Spain
        • Recruiting
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario 12 de octubre
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundación Alcorcón
      • Madrid, Spain
        • Not yet recruiting
        • Hopsital Clínico San Carlos
      • Madrid, Spain
        • Not yet recruiting
        • Hospital Madrid Montepricipe
      • Madrid, Spain
        • Not yet recruiting
        • MD Anderson Cancer Center
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario La Princesa
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Severo Ochoa
      • Madrid, Spain
        • Recruiting
        • Hospital De Mostoles
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fuenlabrada
      • Manresa, Spain
        • Recruiting
        • ALTHAIA Xarxa Asistencial Universitària Manresa
      • Murcia, Spain
        • Recruiting
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Murcia, Spain
        • Recruiting
        • Hospital General Universitario Jose Maria Morales Meseguer
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Málaga, Spain
        • Recruiting
        • Hospital Regional de Málaga Carlos Haya
      • Orense, Spain
        • Recruiting
        • Hospital Santa María Nai
      • Palencia, Spain
        • Not yet recruiting
        • Complejo Hospitalario de Palencia
      • Palmas de Gran Canaria, Spain
        • Not yet recruiting
        • Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
      • Pontevedra, Spain
        • Recruiting
        • Hospital Alvaro Cunqueiro
      • Sabadell, Spain
        • Recruiting
        • Corporacion Sanitaria Parc Tauli
      • Salamanca, Spain
        • Recruiting
        • Hospital Universitario de Salamanca
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario de Valme
      • Tarragona, Spain
        • Recruiting
        • Hospital Universitario Sant Joan de Reus
      • Tenerife, Spain
        • Not yet recruiting
        • Hospital Nuestra Señora de La Candelaria
      • Toledo, Spain
        • Recruiting
        • Hospital Virgen de la Salud
      • Valencia, Spain
        • Recruiting
        • Hospital General Universitario de Valencia
      • Valencia, Spain
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain
        • Recruiting
        • Fundacion Instituto Valenciano de Oncologia
      • Valencia, Spain
        • Recruiting
        • Hospital Arnau Vilanova
      • Valencia, Spain
        • Recruiting
        • Hospital de Sagunto
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario Dr. Peset Aleixandre
      • Vitoria, Spain
        • Recruiting
        • Hospital de Txagorritxu
      • Zaragoza, Spain
        • Recruiting
        • Hospital Universitario Miguel Servet
      • Zaragoza, Spain
        • Recruiting
        • Hospital Clínico Universitario de Zaragoza Lozano Blesa
    • Asturias
      • Avilés, Asturias, Spain
        • Recruiting
        • Hospital San Agustín Avilés
    • Navarra
      • Pamplona, Navarra, Spain
        • Not yet recruiting
        • Complejo Hospitalario de Navarra
    • Tenerife
      • La Laguna, Tenerife, Spain
        • Not yet recruiting
        • Hospital Universitario de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Free Survival (EvFS) in neoadjuvant studies.
Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.

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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS).
Time Frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
Overall Survival (OS) defined as the time from the date of study enrolment to the date of death from any cause.
Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Breast Cancer Research Group

Collaborators

AECC_Asociación Española contra el Cáncer

Investigators

  • Study Director: Study Director, Complejo Hospitalario de Especialidades Virgen de la Victoria
  • Study Director: Study Director, Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Estimated)

January 1, 2047

Study Completion (Estimated)

January 1, 2048

Study Registration Dates

First Submitted

December 29, 2017

First Submitted That Met QC Criteria

December 29, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 13, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEICAM/2016-03
  • 2017-002850-35 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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