Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk
An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
1 other identifier
observational
777
1 country
54
Brief Summary
An observational, Other Designs (OD) post-marketing, multicenter study, which will obtain retrospective data from male patients diagnosed with invasive breast cancer between 2000 and 2019 in the medical oncology departments of hospitals that are associated with Spanish Breast Cancer Research Group (GEICAM) (using information obtained from patient medical histories).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2018
CompletedStudy Start
First participant enrolled
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2025
CompletedFebruary 26, 2025
February 1, 2025
4.5 years
June 22, 2018
February 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (26)
General condition: Age
General condition age will be recorded.
From date of patient breast cancer diagnosis until 2019.
General condition: performance status at diagnosis
Performance status by Eastern Cooperative Oncology Group (ECOG) Scale
From date of patient breast cancer diagnosis until 2019.
General condition and history: substance abuse
Number of Participants With Substance abuse of tobacco and alcohol will be recorded.
From date of patient breast cancer diagnosis until 2019.
Diagnosis of other primary tumors
Diagnosis of other primary tumors synchronous or metachronous, will be recorded.
From date of patient breast cancer diagnosis until 2019.
Body mass index (BMI)
BMI is a value derived from the mass (weight) and height. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
From date of patient breast cancer diagnosis until 2019.
Primary comorbidities
Primary comorbidities will be recorded.
From date of patient breast cancer diagnosis until 2019.
Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition
Mutational status of BRCA or other genes of genetic predisposition will be recorded.
From date of patient breast cancer diagnosis until 2019.
Family history of cancer
Family history of cancer will be recorded.
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: date of diagnosis
Date of diagnosis will be collected.
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: histology
The histology of the tumor will be collected
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: clinical and/or pathological stage
Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system of the Union for International Cancer Control (UICC).
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: hormone-receptor expression
Hormone-receptor expression will be collected
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression
Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: histologic grade
Tumor histologic grade will be collected
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: Ki-67
Tumor Ki-67 proliferation index will be collected
From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: lymphovascular invasion
Number of Participants With Presence of lymphovascular invasion will be collected
From date of patient breast cancer diagnosis until 2017.
Treatment data: date of surgery
Will be collected date of surgery
From date of patient breast cancer diagnosis until 2019.
Treatment data: type of surgery
Number of participants with each type of surgery: mastectomy or lumpectomy or quadrantectomy or lymphadenectomy or sentinel lymph node biopsy will be collected.
From date of patient breast cancer diagnosis until 2019.
Treatment data: type of chemotherapy
Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.
From date of patient breast cancer diagnosis until 2019.
Treatment data: adjuvant radiotherapy
Number of Participants With adjuvant radiotherapy
From date of patient breast cancer diagnosis until 2019.
Treatment data: adjuvant hormonotherapy
Number of Participants With hormonotherapy
From date of patient breast cancer diagnosis until 2019.
Treatment data: other type of anti-cancer treatment
Number of Participants With other type of anti-cancer treatment.
From date of patient breast cancer diagnosis until 2019.
Follow-up data: relapse type
Number of Participants With each relapse type: local, regional or distant
From date of patient breast cancer diagnosis until 2019.
Follow-up data: site of metastatic disease
Number of Participants With site of metastatic disease
From date of patient breast cancer diagnosis until 2019.
Follow-up data: occurrence of other primary tumors
Number of Participants With occurrence of other primary tumors whether or not of breast origin (in situ or invasive).
From date of patient breast cancer diagnosis until 2019.
Follow-up data: current condition
The date of the last review and current clinical condition will be recorded.
From date of patient breast cancer diagnosis until 2019.
Secondary Outcomes (7)
Biological and molecular characteristics analyzed in primary tumors: tumor subtypes
From date of patient breast cancer diagnosis until 2019.
Biological and molecular characteristics analyzed in primary tumors: risk groups
From date of patient breast cancer diagnosis until 2019.
Date and cause of death
From date of patient breast cancer diagnosis until 2019.
Disease-free survival (DFS).
From date of patient breast cancer diagnosis until 2019.
Distant metastasis-free survival (DMFS).
From date of patient breast cancer diagnosis until 2019.
- +2 more secondary outcomes
Study Arms (1)
Male breast cancer
The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites.
Eligibility Criteria
The study target population is all cases of male breast cancer (MBC), diagnosed with invasive breast cancer between the years 2000 and 2019, and treated in the Medical Oncology Departments of participating sites.
You may qualify if:
- Male patients diagnosed with primary invasive breast carcinoma between the years 2000-2019, and who have been treated and/or followed up in the Medical Oncology Departments of participating sites.
- The enrollment of patients who died is allowed.
You may not qualify if:
- Male patients who do not wish to participate in the study for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Breast Cancer Research Grouplead
- Fundación ADEYcollaborator
Study Sites (54)
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, Spain
Hospital Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital General de Granollers
Granollers, Barcelona, Spain
Instituto Catalán de Oncología de L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Consorci Corporació Sànitari Parc Taulí
Sabadell, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Basurto
Bilbao, Bizcaia, Spain
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón, Spain
Hospital General La Mancha Centro
Alcázar de San Juan, Ciudad Real, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Guipúzcoa, Spain
Onkologikoa
Donostia / San Sebastian, Guipúzcoa, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitario San Agustín
Avilés, Principality of Asturias, Spain
Hospital de Tortosa Verge de la Cinta
Tortosa, Tarragona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell
Barcelona, Spain
Hospital Universitari Vall D´Hebrón
Barcelona, Spain
IDOC Centre Médic
Barcelona, Spain
Hospital Virgen de la Luz
Cuenca, Spain
Instituto Catalán de Oncología de Girona
Girona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Juan Ramón Jiménez
Huelva, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Spain
Hospital Universitario Lucus Augusti
Lugo, Spain
GenesisCare Madrid Hospital La Milagrosa
Madrid, Spain
Hospital Central de la Defensa Gómez Ulla
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario La Zarzuela
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Regional Universitario
Málaga, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Universitario Nuestra Señora De Candelaria
Santa Cruz de Tenerife, Spain
Hospital de Sant Pau i Santa Tecla
Tarragona, Spain
Hospital Universitario de Toledo
Toledo, 45007, Spain
Fundación Instituto Valenciano de Oncología
Valencia, Spain
Hospital Arnau de Vilanova
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Universitario Río Hortega
Valladolid, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Quirón Zaragoza
Zaragoza, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Álava, Spain
Related Links
Biospecimen
Tumor tissue and blood samples will be collected and biological and genetic analyses will be performed.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chief Medical Investigator
Hospital Universitario Ramón y Cajal, Madrid, Spain
- STUDY DIRECTOR
Chief Medical Investigator
Fundación Onkologikoa, San Sebastián, Spain
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2018
First Posted
January 11, 2019
Study Start
September 14, 2018
Primary Completion
March 31, 2023
Study Completion
February 24, 2025
Last Updated
February 26, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share