Clinical trial NCT03390894: Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
Official title: Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Breast Cancer Early Stages
Keywords: Long-term Follow-Up
Invasive Breast Cancer Early Stages
Previous Neoadjuvant treatment
Previous Adjuvant treatment
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: AECC_Asociación Española contra el Cáncer
First posted: 2018-01-04
Enrollment: 8000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Event Free Survival (EvFS) in neoadjuvant studies.
timeFrame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
measure: Disease Free Survival (DFS) in adjuvant studies.
timeFrame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
Secondary outcomes:
measure: Overall Survival (OS).
timeFrame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
Other outcomes:
Locations:
city: Avilés
country: Spain
facility: Hospital San Agustín Avilés
state: Asturias
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
city: A Coruña
country: Spain
facility: Complejo Hospitalario A Coruña
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Alicante
country: Spain
facility: Hospital General Universitario de Elche
city: Alicante
country: Spain
facility: Hospital General Universitario de Elda
city: Alicante
country: Spain
facility: Hospital Virgen De Los Lirios
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Consorci Sanitari de Terrassa
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Mutua Terrassa
city: Barcelona
country: Spain
facility: Instituto Catalán Oncología Barcelona Hospital Duran I Reynalds
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cadiz
country: Spain
facility: Complejo Especialidades de Jerez de la Frontera
city: Castelló
country: Spain
facility: Complejo Hospitalario de Castellón
city: Cuenca
country: Spain
facility: Hospital Virgen De La Luz
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Donostia
country: Spain
facility: Hospital Universitario de Cruces
city: Donostia
country: Spain
facility: Hospital Universitario Donostia
city: Donostia
country: Spain
facility: Onkologikoa
city: Gerona
country: Spain
facility: Instituto Catalán de Oncología Gerona Hospital Dr. Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Granada
country: Spain
facility: Hospital Universitario Virgen De Las Nieves
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Huelva
country: Spain
facility: Complejo Hospitalario de Especialidades Juan Ramón Jiménez
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: León
country: Spain
facility: Hospital de León
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hopsital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital de Mostoles
city: Madrid
country: Spain
facility: Hospital general Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Madrid Montepricipe
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Manresa
country: Spain
facility: ALTHAIA Xarxa Asistencial Universitària Manresa
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Murcia
country: Spain
facility: Hospital General Universitario José María Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Regional de Málaga Carlos Haya
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Orense
country: Spain
facility: Hospital santa María Naí
city: Palencia
country: Spain
facility: Complejo Hospitalario de Palencia
city: Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín
city: Pontevedra
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Sabadell
country: Spain
facility: Corporación Sanitaria Parc Taulí
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario de Valme
city: Tarragona
country: Spain
facility: Hospital Universitario Sant Joan De Reus
city: Tenerife
country: Spain
facility: Hospital Nuestra Señora De La Candelaria
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Arnau Vilanova
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital de Sagunto
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politécnic La Fe
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset Aleixandre
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario de Zaragoza Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Complejo Hospitalario de Especialidades Virgen de la Victoria
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital General Universitario Gregorio Marañón
name: Study Director
role: STUDY_DIRECTOR
References: