A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Breast Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
Detailed description
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). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time.
The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.
Interventions
- Other No intervention
Primary outcome measures
- Number of patients with the different breast cancer subtypes and real distribution of them. [Time frame: 8 years]
Secondary outcome measures (4)
- Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk. [Time frame: 8 years]
- Differences in the development disease in the group of male vs female patients. [Time frame: 8 years]
- Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis [Time frame: 8 years]
- Number of participants with specific biomarkers on tumor and blood samples. [Time frame: 8 years]
Eligibility criteria
Inclusion criteria
- 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.
- Availability to medical records access and all data related to the disease management.
Exclusion criteria
None
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 · 40 centers
- Hospital General de Elche — Elche
- Althaia-Xarxa Assistencial de Manresa — Manresa
- Consorci Sanitari de Terrassa — Terrassa
- Hospital Universitario Donostia — San Sebastián
- Hospital Dr. Negrín — Las Palmas de Gran Canaria
- Hospital Universitario Fundación Alcorcón — Alcorcón
- Hospital Universitario de Fuenlabrada — Fuenlabrada
- Hospital Universitario Severo Ochoa — Leganés
- … and 32 more centers
Identifiers
NCT: NCT02819882 · GEICAM 2014-03