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

Recruiting

• 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.

Study Timeline

• Study First Submitted: 2017-12-29
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-04
• Study Start: 2018-01-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2047-01
• Study Completion: 2048-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 8000

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 & 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)

Hospital San Agustín Avilés; 🇪🇸 Avilés, Asturias, Spain

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario de Canarias; 🇪🇸 La Laguna, Tenerife, 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

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