A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
NCT ID: NCT02819882
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1867 participants
OBSERVATIONAL
2016-08-31
2026-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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%).
No intervention
Luminal B-like (HER2 negative) subtype:
Patients that express ER and are either PgR- or low (\< 20%) and/or Ki67 'high' (≥ 14%).
No intervention
Luminal B-like (HER2 positive) subtype:
Patients that express ER and HER2 irrespective of PgR or Ki67 status.
No intervention
HER2-enriched subtype
Patients that express HER2 and don't express ER or PgR.
No intervention
Triple Negative (TN) subtype
Patients who are negative for the expression of ER, PgR and HER2.
No intervention
Interventions
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No intervention
Eligibility Criteria
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Inclusion Criteria
2. Patients who died are allowed to be included on the study.
3. Able and willing to provide written informed consent if they are alive.
4. Age ≥ 18 years.
5. Availability to medical records access and all data related to the disease management.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Novartis
INDUSTRY
AstraZeneca
INDUSTRY
Pfizer
INDUSTRY
Celgene
INDUSTRY
Spanish Breast Cancer Research Group
OTHER
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Director
Role: STUDY_DIRECTOR
Hospital de Donostia, San Sebastián, Spain
Study Director
Role: STUDY_DIRECTOR
Hospital Universitario Gregorio Marañón, Madrid, Spain
Study Director
Role: STUDY_DIRECTOR
Instituto Valenciano de Oncología (IVO), Valencia, Spain
Study Director
Role: STUDY_DIRECTOR
Complejo Hospital Universitario A Coruña (CHUAC), Galicia, Spain
Study Director
Role: STUDY_DIRECTOR
Hospital Universitario Fundación Jimenez Díaz, Madrid, Spain
Locations
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Hospital General de Elche
Elche, Alicante, Spain
Althaia-Xarxa Assistencial de Manresa
Manresa, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Donostia
San Sebastián, Donostia, Spain
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Gran Canaria, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, Spain
Hospital Son Llatzer
Palma de Mallorca, Mallorca, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Universitario de Basurto
Bilbao, Vizcaya, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Complejo Hospitalario Universitario de Albacete
Albacete, , Spain
Hospital San Juan de Alicante
Alicante, , Spain
Hospital Nuestra Señora de Sonsoles
Ávila, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Santa Creu i Sant Pau
Barcelona, , Spain
ICO L´Hospitalet
Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, , Spain
Hospital Moisés Broggi_institut Catalá D´Oncologia
Barcelona, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital de León
León, , Spain
Hospital Lucus Augusti
Lugo, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario de Málaga
Málaga, , Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, , Spain
Hospital Clínico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
IVO-Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hosital General de Valencia
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
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Central Contacts
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Related Links
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Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group
Other Identifiers
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GEICAM 2014-03
Identifier Type: -
Identifier Source: org_study_id
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