Follow-up in Early and Locally Advanced Breast Cancer Patients

May 7, 2026 updated by: European Organisation for Research and Treatment of Cancer - EORTC
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

The objective of this study is to assess follow-up patterns and identify patients with increased levels of physical and/or psychosocial problems after treatment in early breast cancer and locally advanced breast cancer.

830 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.

Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 139 Quality of Life questions, at one single time point.

Statistical analysis includes descriptive statistic for socio-demographic and clinical data, overall and per treatment, age and risk group. Patterns of follow-up will be identified and described overall, and per treatment, age, risk group and country.

Where available, normative data will be used to identify those QoL domains where there is a clinically relevant difference with the general population.

Multivariable model building will be used to build predictive models on the overall population to investigate determinants for the physical, sexual and emotional needs based on the identified PROM outcomes. Factor analysis will be undertaken to investigate the inter-correlations between physical, sexual and emotional needs in the overall population and in the relevant subgroups of interest.

The magnitude of the observed differences will be assessed by clinical important effect size rather than by statistical significance.

Study Type

Observational

Enrollment (Actual)

830

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Onze Lieve Vrouw Ziekenhuis
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium
        • CHU Saint Pierre - CHU Saint-Pierre-Site Porte de Hal
      • Liège, Belgium
        • C.H.U. Sart-Tilman
      • Namur, Belgium
        • CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur
  • France
      • Arras, France
        • Groupe Radiopole Artois - Centre de radiotherapie Marie Curie
    • De
      • Paris, De, France
        • Assistance Publique Hopitaux Paris - Assistance Publique - Hopitaux de Paris - Hopital Tenon
  • Germany
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
      • Wuppertal, Germany
        • HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
  • Italy
      • Bolzano, Italy
        • Ospedale Generale Regionale
      • Florence, Italy
        • Azienda Ospedaliero-Universitaria Careggi
      • Monza, Italy
        • Ospedale San Gerardo
      • Naples, Italy
        • IRCCS - Fondazione G. Pascale
      • Padova, Italy
        • IRCCS - Istituto Oncologico Veneto
      • Roma, Italy
        • Universita Di Roma La Sapienza - Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea
  • Jordan
      • Amman, Jordan
        • King Hussein Cancer Center
  • Netherlands
      • Amsterdam, Netherlands
        • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
  • Poland
      • Gdansk, Poland
        • Medical University of Gdansk
      • Poznan, Poland
        • The Great Poland Cancer Centre
      • Warsaw, Poland
        • Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
  • Spain
      • Córdoba, Spain
        • Hospital Universitario Reina Sofia
      • Madrid, Spain
        • Clinica Universidad de Navarra
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
  • Switzerland
      • Aarau, Switzerland
        • Group Of Private Clinics Hirslanden - Hirslanden Klinik-Tumor Zentrum Aarau
      • Sankt Gallen, Switzerland, 9006
        • Tumor and Breast Center ZeTuP St. Gallen
  • United Kingdom
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
      • London, United Kingdom
        • Barts Health NHS Trust - St. Bartholomew'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.

Description

Inclusion Criteria:

  • Histologically proven Early Breast Cancer (EBC) and Locally Advanced Breast Cancer (LABC) patients who have completed their primary treatment (except endocrine therapy), between 12 months and 36 months after the diagnosis.
  • Disease-free without any evidence of relapse
  • Age ≥ 18 years.
  • Ability to understand and fill out questionnaires.
  • Written informed consent.

Exclusion Criteria:

  • Metastatic breast cancer (defined as secondary spread to other organs, such as bones, lung, liver, mediastinal lymph nodes) or DCIS.
  • Other cancer diagnosis in the past 5 years except non-melanotic skin cancer or cervical intraepithelial neoplasia.
  • Male breast cancer.
  • Patients on maintenance therapy (other than endocrine therapy).
  • Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
  • Any psychological (including preexisting psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 18 months after first patient inclusion
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
18 months after first patient inclusion
Health-related quality of life
Time Frame: 18 months after first patient inclusion
It will be evaluated using self-administered EORTC-QLQ-BR-45 questionnaire
18 months after first patient inclusion
Health-related quality of life
Time Frame: 18 months after first patient inclusion
It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
18 months after first patient inclusion
Health-related quality of life
Time Frame: 18 months after first patient inclusion
It will be evaluated using self-administered EORTC Sexual Health Questionnaire
18 months after first patient inclusion
Health-related quality of life
Time Frame: 18 months after first patient inclusion
It will be evaluated using self-administered Distress Thermometer
18 months after first patient inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2020

Primary Completion (Actual)

August 14, 2025

Study Completion (Actual)

August 14, 2025

Study Registration Dates

First Submitted

February 28, 2019

First Submitted That Met QC Criteria

February 28, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-1617-QLG-BCG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe