Breast CancerNCT03859453
Follow-up in Early and Locally Advanced Breast Cancer Patients
An observational study of Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 10 countries.
Trial summary
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 830 participants
- Where
- 28 sitesin 10 countries
- Study dates
- 14 Oct 2020to 14 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 10 countries.
28 sites in 10 countries
Italy6 sites
Ospedale Generale Regionale
Bolzano
Azienda Ospedaliero-Universitaria Careggi
Florence
Ospedale San Gerardo
Monza
IRCCS - Fondazione G. Pascale
Naples
IRCCS - Istituto Oncologico Veneto
Padova
Universita Di Roma La Sapienza - Universita Degli Studi Di Roma La Sapienza - Ospedale Sant'Andrea
Roma
Belgium5 sites
Onze Lieve Vrouw Ziekenhuis
Aalst
CHU Saint Pierre - CHU Saint-Pierre-Site Porte de Hal
Brussels
Cliniques Universitaires Saint-Luc
Brussels
C.H.U. Sart-Tilman
Liège
CHU-UCL Namur - CHU Site Sainte-Elisabeth-UCL Namur
Namur
Spain4 sites
Hospital Universitario Reina Sofia
Córdoba
Clinica Universidad de Navarra
Madrid
Hospital Universitario Ramon y Cajal
Madrid
Complejo Hospitalario de Navarra
Pamplona
Poland3 sites
Medical University Of Gdansk
Gdansk
The Great Poland Cancer Centre
Poznan
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
France2 sites
Groupe Radiopole Artois - Centre de radiotherapie Marie Curie
Arras
Assistance Publique Hopitaux Paris - Assistance Publique - Hopitaux de Paris - Hopital Tenon
Paris, De
Germany2 sites
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
Leipzig
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal
Switzerland2 sites
Group Of Private Clinics Hirslanden - Hirslanden Klinik-Tumor Zentrum Aarau
Aarau
Tumor and Breast Center ZeTuP St. Gallen
Sankt Gallen, 9006
United Kingdom2 sites
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds
Barts Health NHS Trust - St. Bartholomew'S Hospital
London
Netherlands1 site
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam
About this study
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.
Read the 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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
Measured: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC-QLQ-BR-45 questionnaire
Measured: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
Measured: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC Sexual Health Questionnaire
Measured: 18 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered Distress Thermometer
Measured: 18 months after first patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start14 Oct 2020
- Primary completion14 Aug 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859453
- Sponsor's protocol ID
- EORTC-1617-QLG-BCG
- Status last verified
- May 2026
- First submitted
- 28 Feb 2019
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up in Early and Locally Advanced Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03859453
- Acronym / sponsor ID
- EORTC-1617-QLG-BCG
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 14 Aug 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- EBC and LABC cancer patients after primary treatment attending participating hospitals for routine follow-up.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life
Time frame: 18 months after first patient inclusion
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
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
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
Health-related quality of life
Time frame: 18 months after first patient inclusion
It will be evaluated using self-administered EORTC Sexual Health Questionnaire
Health-related quality of life
Time frame: 18 months after first patient inclusion
It will be evaluated using self-administered Distress Thermometer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 28 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy, Belgium, Spain, Poland, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 18 months after first patient inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.