A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)

NCT02819882 | Recruiting

• 1 other identifier: GEICAM 2014-03
• Study Type: observational
• Target: 1,867
• Locations: 1 country
• Sites: 40

Brief Summary

This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.

Conditions

Breast Neoplasms

Keywords

Unresectable; locally; advanced; metastatic disease

Outcome Measures

Primary Outcomes (1)

• 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

  8 years

Secondary Outcomes (4)

• Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk.

  8 years

• Differences in the development disease in the group of male vs female patients.

  8 years

• Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis

  8 years

• Number of participants with specific biomarkers on tumor and blood samples.

  8 years

Study Arms (5)

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%).

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%).

Other: No intervention

Luminal B-like (HER2 positive) subtype:

Patients that express ER and HER2 irrespective of PgR or Ki67 status.

Other: No intervention

HER2-enriched subtype

Patients that express HER2 and don't express ER or PgR.

Other: No intervention

Triple Negative (TN) subtype

Patients who are negative for the expression of ER, PgR and HER2.

Other: No intervention

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Hoffmann-La Roche: collaborator
• Novartis: collaborator
• AstraZeneca: collaborator
• Pfizer: collaborator
• Celgene: collaborator

Study Sites (40)

Hospital General de Elche

Elche, Alicante, 03203, Spain

RECRUITING

Althaia-Xarxa Assistencial de Manresa

Manresa, Barcelona, 08243, Spain

RECRUITING

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Donostia, 20014, Spain

RECRUITING

Hospital Dr. Negrín

Las Palmas de Gran Canaria, Gran Canaria, 35010, Spain

RECRUITING

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

RECRUITING

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

RECRUITING

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

RECRUITING

Hospital Infanta Sofía

San Sebastián de los Reyes, Madrid, 28702, Spain

RECRUITING

Hospital Son Llatzer

Palma de Mallorca, Mallorca, 07198, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Tenerife, 38320, Spain

RECRUITING

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

RECRUITING

Hospital Universitario de Basurto

Bilbao, Vizcaya, 48013, Spain

RECRUITING

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

RECRUITING

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

RECRUITING

Hospital San Juan de Alicante

Alicante, 03550, Spain

RECRUITING

Hospital Nuestra Señora de Sonsoles

Ávila, 05004, Spain

RECRUITING

Hospital del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

WITHDRAWN

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

ICO L´Hospitalet

Barcelona, 08908, Spain

RECRUITING

Hospital Universitario Germans Trias i Pujol

Barcelona, 08916, Spain

RECRUITING

Hospital Moisés Broggi_institut Catalá D´Oncologia

Barcelona, 08970, Spain

RECRUITING

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

RECRUITING

Hospital de León

León, 24071, Spain

RECRUITING

Hospital Lucus Augusti

Lugo, 27003, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Hospital Universitario de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

RECRUITING

Hospital Clínico Universitario de Salamanca

Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Virgen de la Salud

Toledo, 45004, Spain

RECRUITING

IVO-Instituto Valenciano de Oncología

Valencia, 46009, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hosital General de Valencia

Valencia, 46014, Spain

RECRUITING

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

RECRUITING

Hospital Clínico Lozano Blesa

Zaragoza, 50009, Spain

RECRUITING

Hospital Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Related Links

• Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Primary and metastatic lesion tissue samples

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 Jimenez Díaz, Madrid, Spain

  STUDY DIRECTOR

Central Study Contacts

MS Study Project Manager

CONTACT

+34 916892870; inicio_ensayos@geicam.org

Start-Up Unit Manager

CONTACT

+34 916892870; inicio_ensayos@geicam.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 30, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (40)