Clinical trial · Observational
Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
NCT03390894CI-TRIAL-00089658recruitingClinicalTrials.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)
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
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 |
|---|---|---|---|
| Invasive Breast Cancer Early Stages | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Event Free Survival (EvFS) in neoadjuvant studies.
- timeFrame
- Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
- description
- 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.
- measure
- Disease Free Survival (DFS) in adjuvant studies.
- timeFrame
- Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
- description
- 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)
- measure
- Overall Survival (OS).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.