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

Overview

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

Detailed description

One consequence of the improvement in survival rates of certain tumors such as breast cancer is the increase in the number of patients available for long-term follow-up in randomized controlled clinical trials. This long follow-up allows an additional long-term evaluation of the efficacy, as well as of the sequelae related to the treatments that may occur beyond the time of the primary analysis.

The target population of the study are all patients who were included in neoadjuvant and adjuvant clinical trials of GEICAM performed by the goup since 1998 in the medical oncology units of the participating sites, ensuring a follow-up of patients of approximately 30 years. This will allow to describe the long-term evolution of the patients with invasive breast cancer in early stages.

The information obtained will be very useful to professionals involved in the diagnosis, treatment and monitoring of breast cancer, hospital managers, patients with this condition and society in general. This study provides data of great interest for the estimation of long-term disease requirements.

Primary outcome measures

• Event Free Survival (EvFS) in neoadjuvant studies. [Time frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.]
• Disease Free Survival (DFS) in adjuvant studies. [Time frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.]

Secondary outcome measures (1)

• Overall Survival (OS). [Time frame: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Spain · 73 centers

• Complejo Hospitalario de Navarra — Pamplona
• Hospital San Agustín Avilés — Avilés
• Hospital Universitario de Canarias — San Cristóbal de La Laguna
• Centro Oncológico de Galicia — A Coruña
• Complejo Hospitalario A Coruña — A Coruña
• Complejo Hospitalario Universitario de Albacete — Albacete
• Hospital General Universitario de Alicante — Alicante
• Hospital General Universitario de Elche — Alicante
• … and 65 more centers

Identifiers

NCT: NCT03390894 · GEICAM/2016-03 · 2017-002850-35

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗