Breast NeoplasmsREGISTEMNCT02819882
A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
An observational study of Breast Neoplasms, run by Spanish Breast Cancer Research Group at 40 sites in Spain.
Trial summary
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- How many people
- 1,867 participants
- Where
- 40 sitesSpain
- Study dates
- Aug 2016to Jun 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
40 sites in 1 country. Contact the study team or a site near you to ask about taking part.
40 sites in 1 country
Spain40 sites, 39 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
- Recruiting
Complejo Hospitalario Universitario de Albacete
Albacete, 02006
- Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
- Recruiting
Hospital San Juan de Alicante
Alicante, 03550
- Recruiting
Hospital Nuestra Señora de Sonsoles
Ávila, 05004
- Recruiting
Hospital del Mar
Barcelona, 08003
- Withdrawn
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital Santa Creu i Sant Pau
Barcelona, 08041
- Recruiting
ICO L´Hospitalet
Barcelona, 08908
- Recruiting
Hospital Universitario Germans Trias i Pujol
Barcelona, 08916
- Recruiting
Hospital Moisés Broggi_institut Catalá D´Oncologia
Barcelona, 08970
- Recruiting
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013
- Recruiting
Hospital Universitario Reina Sofía
Córdoba, 14004
- Recruiting
Hospital General de Elche
Elche, Alicante, 03203
- Recruiting
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, 28942
- Recruiting
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Gran Canaria, 35010
- Recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
- Recruiting
Hospital de León
León, 24071
- Recruiting
Hospital Lucus Augusti
Lugo, 27003
- Recruiting
Hospital Universitario La Princesa
Madrid, 28006
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
- Recruiting
Hospital Universitario de Málaga
Málaga, 29010
- Recruiting
Althaia-Xarxa Assistencial de Manresa
Manresa, Barcelona, 08243
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, 30120
- Recruiting
Hospital Son Llatzer
Palma de Mallorca, Mallorca, 07198
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31008
- Recruiting
Hospital de Sagunto
Sagunto, Valencia, 46520
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, 37007
- Recruiting
Hospital Universitario Donostia
San Sebastián, Donostia, 20014
- Recruiting
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, 38320
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
- Recruiting
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227
- Recruiting
Hospital Virgen de la Salud
Toledo, 45004
- Recruiting
IVO-Instituto Valenciano de Oncología
Valencia, 46009
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
- Recruiting
Hosital General de Valencia
Valencia, 46014
- Recruiting
Hospital Universitario Dr. Peset
Valencia, 46017
- Recruiting
Hospital Clínico Lozano Blesa
Zaragoza, 50009
- Recruiting
Hospital Miguel Servet
Zaragoza, 50009
About this study
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- No intervention
- Keywords
- Unresectable, locally, advanced, metastatic disease
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: Other: No intervention | |
| Luminal B-like (HER2 negative) subtype: | Patients that express ER and are either PgR- or low (< 20%) and/or Ki67 'high' (≥ 14%). Receives: Other: No intervention | |
| Luminal B-like (HER2 positive) subtype: | Patients that express ER and HER2 irrespective of PgR or Ki67 status. Receives: Other: No intervention | |
| HER2-enriched subtype | Patients that express HER2 and don't express ER or PgR. Receives: Other: No intervention | |
| Triple Negative (TN) subtype | Patients who are negative for the expression of ER, PgR and HER2. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 years
Secondary outcomes (4)
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.
Measured: 8 years
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.
Measured: 8 years
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
Measured: 8 years
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.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2032 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,867 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Novartis, AstraZeneca, Pfizer, Celgene
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauStudy Director, Study director, Hospital de Donostia, San Sebastián, SpainStudy Director, Study director, Hospital Universitario Gregorio Marañón, Madrid, SpainStudy Director, Study director, Instituto Valenciano de Oncología (IVO), Valencia, SpainStudy Director, Study director, Complejo Hospital Universitario A Coruña (CHUAC), Galicia, SpainStudy Director, Study director, Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819882
- Sponsor's protocol ID
- GEICAM 2014-03
- Acronym
- REGISTEM
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2016
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT02819882
- Acronym / sponsor ID
- REGISTEM / GEICAM 2014-03
- Conditions
- Breast Neoplasms
- Keywords
- Unresectable, locally, advanced, metastatic disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,867 participants (estimated)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Novartis, AstraZeneca, Pfizer, Celgene
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Luminal A-like subtype | – | Other: No interventionPatients that express Estrogen receptor (ER), express Progesterone Receptor (PgR)+ (≥ 20%), don't express HER2 and have Ki-67 'low' (< 14%). |
| Luminal B-like (HER2 negative) subtype: | – | Other: No interventionPatients that express ER and are either PgR- or low (< 20%) and/or Ki67 'high' (≥ 14%). |
| Luminal B-like (HER2 positive) subtype: | – | Other: No interventionPatients that express ER and HER2 irrespective of PgR or Ki67 status. |
| HER2-enriched subtype | – | Other: No interventionPatients that express HER2 and don't express ER or PgR. |
| Triple Negative (TN) subtype | – | Other: No interventionPatients who are negative for the expression of ER, PgR and HER2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | HER2-enriched subtype, Luminal A-like subtype, Luminal B-like (HER2 negative) subtype:, Luminal B-like (HER2 positive) subtype:, Triple Negative (TN) subtype |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Spanish Breast Cancer Research Group at 40 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MS Study Project Manager (+34 916892870, inicio_ensayos@geicam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with the different breast cancer subtypes and real distribution of them. (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.