NCT03390894

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 8,000 (estimated)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Invasive Breast Cancer Early Stages

Timeline

• Start date: 2018-01-18
• Primary completion: 2047-01-01
• Completion: 2048-01-01
• First posted: 2018-01-04
• Last updated: 2025-05-14

Locations

73 sites across 1 country: Spain