Invasive Breast Cancer Early Stages
Conditions
Keywords
Long-term Follow-Up, Invasive Breast Cancer Early Stages, Previous Neoadjuvant treatment, Previous Adjuvant treatment
Brief 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.
Interventions
None listed
Sponsors
AECC_Asociación Española contra el Cáncer
Spanish Breast Cancer Research Group
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival (EvFS) in neoadjuvant studies. | Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. | 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. |
| Disease Free Survival (DFS) in adjuvant studies. | Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS). | Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately. | Overall Survival (OS) defined as the time from the date of study enrolment to the date of death from any cause. |
Countries
Spain
Contacts
Primary ContactStudy Project Manager
Backup ContactStart-Up Unit Manager
Outcome results
None listed