Clinical trial · Observational
Follow-up in Early and Locally Advanced Breast Cancer Patients
NCT03859453CI-TRIAL-00111257completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A cross-sectional follow-up study of Early and Locally Advanced Breast Cancer patients after primary treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Health-related quality of life
- timeFrame
- 18 months after first patient inclusion
- description
- It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
- measure
- Health-related quality of life
- timeFrame
- 18 months after first patient inclusion
- description
- It will be evaluated using self-administered EORTC-QLQ-BR-45 questionnaire
- measure
- Health-related quality of life
- timeFrame
- 18 months after first patient inclusion
- description
- It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
- measure
- Health-related quality of life
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.