Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
- Conditions
- Invasive Breast Cancer Early Stages
- Registration Number
- NCT03390894
- Lead Sponsor
- Spanish Breast Cancer Research Group
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 8000
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event Free Survival (EvFS) in neoadjuvant studies. 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.Disease Free Survival (DFS) in adjuvant studies. 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.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS). 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.
Trial Locations
- Locations (73)
Centro Oncológico de Galicia
🇪🇸A Coruña, Spain
Complejo Hospitalario Universitario de Albacete
🇪🇸Albacete, Spain
Hospital Infanta Cristina
🇪🇸Badajoz, Spain
Hospital General Universitario de Elche
🇪🇸Alicante, Spain
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Universitario Mutua Terrassa
🇪🇸Barcelona, Spain
Hospital Virgen De Los Lirios
🇪🇸Alicante, Spain
Complejo Especialidades de Jerez de la Frontera
🇪🇸Cadiz, Spain
Hospital Universitario Puerta del Mar
🇪🇸Cádiz, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Virgen De La Luz
🇪🇸Cuenca, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Complejo Hospitalario A Coruña
🇪🇸A Coruña, Spain
Hospital San Agustín Avilés
🇪🇸Avilés, Asturias, Spain
Consorci Sanitari de Terrassa
🇪🇸Barcelona, Spain
Hospital General Universitario de Elda
🇪🇸Alicante, Spain
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Arnau Vilanova
🇪🇸Valencia, Spain
Complejo Hospitalario de Castellón
🇪🇸Castelló, Spain
Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
🇪🇸Palmas de Gran Canaria, Spain
Hospital Álvaro Cunqueiro
🇪🇸Pontevedra, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario de Zaragoza Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Tenerife, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital Universitario de Cruces
🇪🇸Donostia, Spain
Hospital Universitario Virgen De Las Nieves
🇪🇸Granada, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital Universitario Donostia
🇪🇸Donostia, Spain
Onkologikoa
🇪🇸Donostia, Spain
Instituto Catalán de Oncología Gerona Hospital Dr. Josep Trueta
🇪🇸Gerona, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Spain
Complejo Hospitalario de Especialidades Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital Universitario San Cecilio
🇪🇸Granada, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital de León
🇪🇸León, Spain
Hospital Madrid Montepricipe
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸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
ALTHAIA Xarxa Asistencial Universitària Manresa
🇪🇸Manresa, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital santa María Naí
🇪🇸Orense, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Regional de Málaga Carlos Haya
🇪🇸Málaga, Spain
Complejo Hospitalario de Palencia
🇪🇸Palencia, Spain
Corporación Sanitaria Parc Taulí
🇪🇸Sabadell, Spain
Hospital Universitario de Valme
🇪🇸Sevilla, Spain
Hospital Nuestra Señora De La Candelaria
🇪🇸Tenerife, Spain
Hospital Universitario Sant Joan De Reus
🇪🇸Tarragona, Spain
Fundación Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Spain
Hospital de Txagorritxu
🇪🇸Vitoria, Spain
Hospital de Sagunto
🇪🇸Valencia, Spain
Hospital Universitari i Politécnic La Fe
🇪🇸Valencia, Spain
Hospital Universitario Dr. Peset Aleixandre
🇪🇸Valencia, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Hopsital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital general Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital General Universitario José María Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸Madrid, Spain
Hospital Universitario de Basurto
🇪🇸Bilbao, Spain
Hospital de Mostoles
🇪🇸Madrid, Spain
Hospital Universitario Fuenlabrada
🇪🇸Madrid, Spain
Instituto Catalán Oncología Barcelona Hospital Duran I Reynalds
🇪🇸Barcelona, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain