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

Invasive Breast Cancer Early Stages Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03390894
• Other study ID #: GEICAM/2016-03
• Secondary ID: 2017-002850-35
• Status: Recruiting
• Start date: January 18, 2018
• Est. completion date: January 2048

Study information

• Verified date: April 2024
• Source: Spanish Breast Cancer Research Group
• Contact: Study Project Manager
• Phone: 00346592870
• Email: inicio_ensayos[@]geicam.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: January 2048
• Est. primary completion date: January 2047
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer Early Stages

Locations

Country	Name	City	State
Spain	Centro Oncológico de Galicia	A Coruña
Spain	Complejo Hospitalario A Coruña	A Coruña
Spain	Complejo Hospitalario Universitario de Albacete	Albacete
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital General Universitario de Elche	Alicante
Spain	Hospital General Universitario de Elda	Alicante
Spain	Hospital Virgen De Los Lirios	Alicante
Spain	Hospital San Agustín Avilés	Avilés	Asturias
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitari Germans Trias i Pujol	Badalona
Spain	Consorci Sanitari de Terrassa	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Mutua Terrassa	Barcelona
Spain	Instituto Catalán Oncología Barcelona Hospital Duran I Reynalds	Barcelona
Spain	Hospital Universitario de Basurto	Bilbao
Spain	Hospital Universitario de Burgos	Burgos
Spain	Complejo Especialidades de Jerez de la Frontera	Cadiz
Spain	Hospital Universitario Puerta del Mar	Cádiz
Spain	Complejo Hospitalario de Castellón	Castelló
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Virgen De La Luz	Cuenca
Spain	Hospital Universitario de Cruces	Donostia
Spain	Hospital Universitario Donostia	Donostia
Spain	Onkologikoa	Donostia
Spain	Instituto Catalán de Oncología Gerona Hospital Dr. Josep Trueta	Gerona
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario Virgen De Las Nieves	Granada
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Complejo Hospitalario de Especialidades Juan Ramón Jiménez	Huelva
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario de Canarias	La Laguna	Tenerife
Spain	Hospital de León	León
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hopsital Clínico San Carlos	Madrid
Spain	Hospital de Mostoles	Madrid
Spain	Hospital general Universitario Gregorio Marañón	Madrid
Spain	Hospital Madrid Montepricipe	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fuenlabrada	Madrid
Spain	Hospital Universitario Fundación Alcorcón	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Severo Ochoa	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Regional de Málaga Carlos Haya	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	ALTHAIA Xarxa Asistencial Universitària Manresa	Manresa
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital General Universitario José María Morales Meseguer	Murcia
Spain	Hospital santa María Naí	Orense
Spain	Complejo Hospitalario de Palencia	Palencia
Spain	Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín	Palmas de Gran Canaria
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Hospital Álvaro Cunqueiro	Pontevedra
Spain	Corporación Sanitaria Parc Taulí	Sabadell
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Universitario Sant Joan De Reus	Tarragona
Spain	Hospital Nuestra Señora De La Candelaria	Tenerife
Spain	Hospital Virgen de la Salud	Toledo
Spain	Fundación Instituto Valenciano de Oncología	Valencia
Spain	Hospital Arnau Vilanova	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital de Sagunto	Valencia
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politécnic La Fe	Valencia
Spain	Hospital Universitario Dr. Peset Aleixandre	Valencia
Spain	Hospital de Txagorritxu	Vitoria
Spain	Hospital Clínico Universitario de Zaragoza Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	AECC_Asociación Española contra el Cáncer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Overall Survival (OS).	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.

External Links

•   Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group