ONG-TERM FOLLOW-UP STUDY OF EARLY STAGE BREAST CANCER PATIENTS INCLUDED IN GEICAM STUDIES

Phase 1

• Conditions: Patients with invasive breast cancer in early stages; MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-502706-33-00
• Lead Sponsor: Grupo Espanol De Investigacion En Cancer De Mama

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-14
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 8000

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

Patients 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the long-term evolution of the patients with invasive breast cancer in early stages included in GEICAM neoadjuvant and adjuvant clinical trials. Will be studied the frequency, type and location of the first relapse.;Secondary Objective: Overall survival., Disease free survival (in adjuvant patients)., Event-free survival (in neoadjuvant patients)., Cause of death.;Primary end point(s): Dates of disease relapse (local, regional or distant) and second primary tumors. Event Free Survival (EvFS) in neoadjuvant studies. Event Free Survival (EFS) in adjuvant studies.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Death date and whether or not it is related to breast cancer. Overall Survival (OS).