Invasive Breast Cancer Early StagesNCT03390894

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

An observational study of Invasive Breast Cancer Early Stages, run by Spanish Breast Cancer Research Group at 73 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Invasive Breast Cancer Early Stages
How many people: 8,000 participants
Where: 73 sitesSpain
Study dates: 18 Jan 2018to Jan 2048
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

73 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Study Project Manager contact

00346592870

inicio_ensayos@geicam.org

Start-Up Unit Manager contact

00346592870

inicio_ensayos@geicam.org

City, postcode or hospital

Sites recruiting now only

73 sites in 1 country

Spain73 sites, 73 recruiting

Centro Oncológico de Galicia
A Coruña
Recruiting
Complejo Hospitalario A Coruña
A Coruña
Recruiting
Complejo Hospitalario Universitario de Albacete
Albacete
Recruiting
Hospital General Universitario de Alicante
Alicante
Recruiting
Hospital General Universitario de Elche
Alicante
Recruiting
Hospital General Universitario de Elda
Alicante
Recruiting
Hospital Virgen De Los Lirios
Alicante
Recruiting
Hospital San Agustín Avilés
Avilés, Principality of Asturias
Recruiting
Hospital Infanta Cristina
Badajoz
Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona
Recruiting
Consorci Sanitari de Terrassa
Barcelona
Recruiting
Hospital Clinic i Provincial
Barcelona
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona
Recruiting
Hospital del Mar
Barcelona
Recruiting
Hospital Universitario Mutua Terrassa
Barcelona
Recruiting
Instituto Catalán Oncología Barcelona Hospital Duran I Reynalds
Barcelona
Recruiting
Hospital Universitario de Basurto
Bilbao
Recruiting
Hospital Universitario de Burgos
Burgos
Recruiting
Complejo Especialidades de Jerez de la Frontera
Cadiz
Recruiting
Hospital Universitario Puerta del Mar
Cadiz
Recruiting
Complejo Hospitalario de Castellón
Castelló
Recruiting
Hospital Universitario Reina Sofía
Córdoba
Recruiting
Hospital Virgen De La Luz
Cuenca
Recruiting
Hospital Universitario de Cruces
Donostia / San Sebastian
Recruiting
Hospital Universitario Donostia
Donostia / San Sebastian
Recruiting
Onkologikoa
Donostia / San Sebastian
Recruiting
Instituto Catalán de Oncología Gerona Hospital Dr. Josep Trueta
Girona
Recruiting
Hospital Universitario San Cecilio
Granada
Recruiting
Hospital Universitario Virgen De Las Nieves
Granada
Recruiting
Hospital Universitario de Guadalajara
Guadalajara
Recruiting
Complejo Hospitalario de Especialidades Juan Ramón Jiménez
Huelva
Recruiting
Complejo Hospitalario de Jaén
Jaén
Recruiting
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria
Not yet recruiting
Hospital de León
León
Recruiting
Hospital Universitario Lucus Augusti
Lugo
Recruiting
Hopsital Clínico San Carlos
Madrid
Not yet recruiting
Hospital de Mostoles
Madrid
Recruiting
Hospital general Universitario Gregorio Marañón
Madrid
Recruiting
Hospital Madrid Montepricipe
Madrid
Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid
Recruiting
Hospital Universitario Fuenlabrada
Madrid
Recruiting
Hospital Universitario Fundación Alcorcón
Madrid
Recruiting
Hospital Universitario La Paz
Madrid
Recruiting
Hospital Universitario La Princesa
Madrid
Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Recruiting
Hospital Universitario Severo Ochoa
Madrid
Recruiting
MD Anderson Cancer Center
Madrid
Not yet recruiting
Hospital Regional de Málaga Carlos Haya
Málaga
Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Recruiting
ALTHAIA Xarxa Asistencial Universitària Manresa
Manresa
Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Recruiting
Hospital General Universitario José María Morales Meseguer
Murcia
Recruiting
Hospital santa María Naí
Ourense
Recruiting
Complejo Hospitalario de Palencia
Palencia
Not yet recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre
Not yet recruiting
Hospital Álvaro Cunqueiro
Pontevedra
Recruiting
Corporación Sanitaria Parc Taulí
Sabadell
Recruiting
Hospital Universitario de Salamanca
Salamanca
Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife
Not yet recruiting
Hospital Nuestra Señora De La Candelaria
Santa Cruz de Tenerife
Not yet recruiting
Hospital Universitario de Valme
Seville
Recruiting
Hospital Universitario Sant Joan De Reus
Tarragona
Recruiting
Hospital Virgen de la Salud
Toledo
Recruiting
Fundación Instituto Valenciano de Oncología
Valencia
Recruiting
Hospital Arnau Vilanova
Valencia
Recruiting
Hospital Clínico Universitario de Valencia
Valencia
Recruiting
Hospital de Sagunto
Valencia
Recruiting
Hospital General Universitario de Valencia
Valencia
Recruiting
Hospital Universitari i Politécnic La Fe
Valencia
Recruiting
Hospital Universitario Dr. Peset Aleixandre
Valencia
Recruiting
Hospital de Txagorritxu
Vitoria-Gasteiz
Recruiting
Hospital Clínico Universitario de Zaragoza Lozano Blesa
Zaragoza
Recruiting
Hospital Universitario Miguel Servet
Zaragoza
Recruiting

Other trials in Spain

About this study

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

Read the 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.

Conditions: Invasive Breast Cancer Early Stages
Keywords: Long-term Follow-Up, Invasive Breast Cancer Early Stages, Previous Neoadjuvant treatment, Previous Adjuvant treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 2018Jan 2048

First posted4 Jan 2018
Study start18 Jan 2018
Primary completionJan 2047 (estimated)
Study completionJan 2048 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Invasive Breast Cancer Early StagesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 8,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03390894
Sponsor's protocol ID: GEICAM/2016-03
Other IDs: 2017-002850-35, 2017
Status last verified: Oct 2026
First submitted: 29 Dec 2017
Last updated: 13 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Study Project Manager

00346592870

inicio_ensayos@geicam.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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