Clinical trial NCT03800355: Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk
Official title: An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer, Male
Keywords: Breast Cancer in males
Observational
Gene Sequencing
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Fundación ADEY
First posted: 2019-01-11
Enrollment: 777
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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).

Detailed description: One of the objectives of this project is to ensure representativeness of the cases referred to. Accordingly, participating sites agree to enroll in the study male patients who were diagnosed with breast cancer in the period between 2000 and 2019.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Male patients who do not wish to participate in the study for any reason.

Primary outcomes:
measure: General condition: Age
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: General condition: performance status at diagnosis
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: General condition and history: substance abuse
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Diagnosis of other primary tumors
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Body mass index (BMI)
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Primary comorbidities
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Family history of cancer
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: date of diagnosis
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: histology
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: clinical and/or pathological stage
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: hormone-receptor expression
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: histologic grade
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: Ki-67
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Anatomopathological characteristics of the tumor: lymphovascular invasion
timeFrame: From date of patient breast cancer diagnosis until 2017.
measure: Treatment data: date of surgery
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Treatment data: type of surgery
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Treatment data: type of chemotherapy
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Treatment data: adjuvant radiotherapy
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Treatment data: adjuvant hormonotherapy
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Treatment data: other type of anti-cancer treatment
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Follow-up data: relapse type
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Follow-up data: site of metastatic disease
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Follow-up data: occurrence of other primary tumors
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Follow-up data: current condition
timeFrame: From date of patient breast cancer diagnosis until 2019.
Secondary outcomes:
measure: Biological and molecular characteristics analyzed in primary tumors: tumor subtypes
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Biological and molecular characteristics analyzed in primary tumors: risk groups
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Date and cause of death
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Disease-free survival (DFS).
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Distant metastasis-free survival (DMFS).
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Progression-free survival (PFS).
timeFrame: From date of patient breast cancer diagnosis until 2019.
measure: Overall survival (OS).
timeFrame: From date of patient breast cancer diagnosis until 2019.
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: A Coruña
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Avilés
country: Spain
facility: Hospital Universitario San Agustín
state: Asturias
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Instituto Catalán de Oncología de L'Hospitalet
state: Barcelona
city: Sabadell
country: Spain
facility: Consorci Corporació Sànitari Parc Taulí
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
state: Bizcaia
city: Castellón De La Plana
country: Spain
facility: Consorcio Hospitalario Provincial de Castellón
state: Castellón
city: Alcázar De San Juan
country: Spain
facility: Hospital General La Mancha Centro
state: Ciudad Real
city: Donostia-San Sebastián
country: Spain
facility: Hospital Universitario Donostia
state: Guipúzcoa
city: Donostia-San Sebastián
country: Spain
facility: Onkologikoa
state: Guipúzcoa
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Pozuelo De Alarcón
country: Spain
facility: Hospital Universitario Quirónsalud Madrid
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
city: Tortosa
country: Spain
facility: Hospital de Tortosa Verge de la Cinta
state: Tarragona
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D´Hebrón
city: Barcelona
country: Spain
facility: IDOC Centre Médic
city: Cuenca
country: Spain
facility: Hospital Virgen de la Luz
city: Girona
country: Spain
facility: Instituto Catalán de Oncología de Girona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular-Materno Infantil
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: GenesisCare Madrid Hospital La Milagrosa
city: Madrid
country: Spain
facility: Hospital Central de la Defensa Gómez Ulla
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario La Zarzuela
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer
city: Málaga
country: Spain
facility: Hospital Regional Universitario
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora De Candelaria
city: Tarragona
country: Spain
facility: Hospital de Sant Pau i Santa Tecla
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Quirón Zaragoza
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario de Araba
state: Álava
Study officials:
affiliation: Hospital Universitario Ramón y Cajal, Madrid, Spain
name: Chief Medical Investigator
role: STUDY_DIRECTOR
affiliation: Fundación Onkologikoa, San Sebastián, Spain
name: Chief Medical Investigator
role: STUDY_DIRECTOR
References: