About this trial
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016 onwards.
Patients who died are allowed to be included on the study.
Able and willing to provide written informed consent if they are alive.
Age ≥ 18 years.
Disqualifiers
None
Trial population
The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis).
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other intervention
Treatment groups
Trial outcomes
Primary outcomes
Number of patients with the different breast cancer subtypes and real distribution of them.
Number of patients with the different breast cancer subtypes (Luminal A-like, Luminal B-like \[HER2 negative\], Luminal B-like \[HER2 positive\], HER2-enriched and Triple Negative) of the unresectable locally advanced or metastatic disease
Secondary outcomes
Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.
It will be performed a table with patient and tumor characteristics including only those patients with heredofamiliar risk.
Differences in the development disease in the group of male vs female patients.
It will be performed an analysis separately for each subtype and by male and female and it will analyse if there are any significative difference between them.
Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
Number of participants with specific biomarkers on tumor and blood samples.
to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Spanish Breast Cancer Research Group
Lead sponsor
Hoffmann-La Roche
Collaborator
Novartis
Collaborator
AstraZeneca
Collaborator
Pfizer
Collaborator
Celgene
Collaborator