A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC) (REGISTEM)
April 1, 2026 updated by: Spanish Breast Cancer Research Group
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
Study Overview
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.
Study Type
Observational
Enrollment (Estimated)
1867
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: MS Study Project Manager
- Phone Number: +34 916892870
- Email: inicio_ensayos@geicam.org
Study Contact Backup
- Name: Start-Up Unit Manager
- Phone Number: +34 916892870
- Email: inicio_ensayos@geicam.org
Study Locations
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A Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruña
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Albacete, Spain, 02006
- Recruiting
- Complejo Hospitalario Universitario de Albacete
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Alicante, Spain, 03550
- Recruiting
- Hospital San Juan de Alicante
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Barcelona, Spain, 08003
- Recruiting
- Hospital Del Mar
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Barcelona, Spain, 08041
- Recruiting
- Hospital Santa Creu i Sant Pau
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Barcelona, Spain, 08908
- Recruiting
- ICO L´Hospitalet
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Barcelona, Spain, 08916
- Recruiting
- Hospital Universitario Germans Trias i Pujol
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Barcelona, Spain, 08970
- Recruiting
- Hospital Moisés Broggi_institut Catalá D´Oncologia
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Barcelona, Spain, 08036
- Withdrawn
- Hospital Clinic de Barcelona
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Córdoba, Spain, 14004
- Recruiting
- Hospital Universitario Reina Sofia
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León, Spain, 24071
- Recruiting
- Hospital de León
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Lugo, Spain, 27003
- Recruiting
- Hospital Lucus Augusti
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Madrid, Spain, 28006
- Recruiting
- Hospital Universitario La Princesa
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Madrid, Spain, 28007
- Recruiting
- Hospital General Universitario Gregorio Marañón
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Murcia, Spain, 30120
- Recruiting
- Hospital Clínico Universitario Virgen de la Arrixaca
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Málaga, Spain, 29010
- Recruiting
- Hospital Universitario de Málaga
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Salamanca, Spain, 37007
- Recruiting
- Hospital Clinico Universitario de Salamanca
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Seville, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocío
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Toledo, Spain, 45004
- Recruiting
- Hospital Virgen de la Salud
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Valencia, Spain, 46010
- Recruiting
- Hospital Clínico Universitario de Valencia
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Valencia, Spain, 46017
- Recruiting
- Hospital Universitario Dr. Peset
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Valencia, Spain, 46009
- Recruiting
- IVO-Instituto Valenciano de Oncología
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Valencia, Spain, 46014
- Recruiting
- Hosital General de Valencia
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Zaragoza, Spain, 50009
- Recruiting
- Hospital Clinico Lozano Blesa
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Zaragoza, Spain, 50009
- Recruiting
- Hospital Miguel Servet
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Ávila, Spain, 05004
- Recruiting
- Hospital Nuestra Señora de Sonsoles
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Alicante
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Elche, Alicante, Spain, 03203
- Recruiting
- Hospital General de Elche
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Barcelona
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Manresa, Barcelona, Spain, 08243
- Recruiting
- Althaia-Xarxa Assistencial de Manresa
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Terrassa, Barcelona, Spain, 08227
- Recruiting
- Consorci Sanitari de Terrassa
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Donostia
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San Sebastián, Donostia, Spain, 20014
- Recruiting
- Hospital Universitario Donostia
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Gran Canaria
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Las Palmas de Gran Canaria, Gran Canaria, Spain, 35010
- Recruiting
- Hospital Dr. Negrín
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Madrid
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Alcorcón, Madrid, Spain, 28922
- Recruiting
- Hospital Universitario Fundacion Alcorcon
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Fuenlabrada, Madrid, Spain, 28942
- Recruiting
- Hospital Universitario de Fuenlabrada
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Leganés, Madrid, Spain, 28911
- Recruiting
- Hospital Universitario Severo Ochoa
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San Sebastián de los Reyes, Madrid, Spain, 28702
- Recruiting
- Hospital Infanta Sofía
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Mallorca
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Palma de Mallorca, Mallorca, Spain, 07198
- Recruiting
- Hospital Son Llatzer
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Navarre
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Pamplona, Navarre, Spain, 31008
- Recruiting
- Complejo Hospitalario de Navarra
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Tenerife
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Santa Cruz de Tenerife, Tenerife, Spain, 38320
- Recruiting
- Hospital Universitario de Canarias
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Valencia
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Sagunto, Valencia, Spain, 46520
- Recruiting
- Hospital de Sagunto
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Vizcaya
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Bilbao, Vizcaya, Spain, 48013
- Recruiting
- Hospital Universitario de Basurto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study 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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Luminal A-like subtype
Patients that express Estrogen receptor (ER), express Progesterone Receptor (PgR)+ (≥ 20%), don't express HER2 and have Ki-67 'low' (< 14%).
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Luminal B-like (HER2 negative) subtype:
Patients that express ER and are either PgR- or low (< 20%) and/or Ki67 'high' (≥ 14%).
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Luminal B-like (HER2 positive) subtype:
Patients that express ER and HER2 irrespective of PgR or Ki67 status.
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HER2-enriched subtype
Patients that express HER2 and don't express ER or PgR.
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|
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Triple Negative (TN) subtype
Patients who are negative for the expression of ER, PgR and HER2.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with the different breast cancer subtypes and real distribution of them.
Time Frame: 8 years
|
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
|
8 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.
Time Frame: 8 years
|
It will be performed a table with patient and tumor characteristics including only those patients with heredofamiliar risk.
|
8 years
|
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Differences in the development disease in the group of male vs female patients.
Time Frame: 8 years
|
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.
|
8 years
|
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Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
Time Frame: 8 years
|
Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis
|
8 years
|
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Number of participants with specific biomarkers on tumor and blood samples.
Time Frame: 8 years
|
to improve the understanding of metastatic breast cancer by performing analysis on tumor and blood samples.
|
8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Study Director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study Director: Study Director, Hospital de Donostia, San Sebastián, Spain
- Study Director: Study Director, Hospital Universitario Gregorio Marañón, Madrid, Spain
- Study Director: Study Director, Instituto Valenciano de Oncología (IVO), Valencia, Spain
- Study Director: Study Director, Complejo Hospital Universitario A Coruña (CHUAC), Galicia, Spain
- Study Director: Study Director, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
June 20, 2016
First Submitted That Met QC Criteria
June 27, 2016
First Posted (Estimated)
June 30, 2016
Study Record Updates
Last Update Posted (Actual)
April 7, 2026
Last Update Submitted That Met QC Criteria
April 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEICAM 2014-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.