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

ConditionInvasive Breast Cancer Early Stages
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSpanish Breast Cancer Research Group

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with invasive breast cancer (early stages) included in neoadjuvant and adjuvant clinical trials with GEICAM's participation.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Event Free Survival (EvFS) in neoadjuvant studies.

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.

Time frame
Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
2

Disease Free Survival (DFS) in adjuvant studies.

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.

Time frame
Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.

Secondary outcomes

1

Overall Survival (OS).

Overall Survival (OS) defined as the time from the date of study enrolment to the date of death from any cause.

Time frame
Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spanish Breast Cancer Research Group

Lead sponsor

AECC_Asociación Española contra el Cáncer

Collaborator

Source ClinicalTrials.gov
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