Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03390894

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Complejo Hospitalario de Navarra, Pamplona, Navarre, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Event Free Survival (EvFS) in neoadjuvant studies.

    Time frame: 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.
  2. Disease Free Survival (DFS) in adjuvant studies.

    Time frame: 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 outcomes

  1. Overall Survival (OS).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Start-Up Unit Manager

CONTACT

[email protected]

00346592870

Study Project Manager

CONTACT

[email protected]

00346592870

Sponsors and collaborators

Lead sponsor

Spanish Breast Cancer Research Group

Other

Collaborators

  • AECC_Asociación Española contra el Cáncer

Registry information

Important dates

Study start
2018
Primary completion
2047
Study completion
2048
First posted
Jan 4, 2018
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.