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

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).

Study Overview

• Status: Completed
• Conditions: Breast Cancer, Male

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.

• Study Type: Observational
• Enrollment (Actual): 777

Contacts and Locations

• Study Contact: Name: Study Project Manager; Phone Number: 00 34 91 659 28 70; Email: inicio_ensayos@geicam.org
• Study Contact Backup: Name: Start-Up Unit Manager; Phone Number: 00 34 91 659 28 70; Email: inicio_ensayos@geicam.org

Study Locations

• Spain
  • A Coruña, Spain
    • Complejo Hospitalario Universitario A Coruña
  • Barcelona, Spain
    • Hospital del Mar
  • Barcelona, Spain
    • Hospital Universitari Vall d´Hebron
  • Barcelona, Spain
    • Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell
  • Barcelona, Spain
    • IDOC Centre Médic
  • Cuenca, Spain
    • Hospital Virgen De La Luz
  • Girona, Spain
    • Instituto Catalán de Oncología de Girona
  • Granada, Spain
    • Hospital Universitario Virgen de las Nieves
  • Huelva, Spain
    • Hospital Juan Ramón Jimenez
  • Jaén, Spain
    • Complejo Hospitalario de Jaén
  • Las Palmas De Gran Canaria, Spain
    • Complejo hospitalario Universitario Insular-Materno Infantil
  • Lugo, Spain
    • Hospital Universitario Lucus Augusti
  • Madrid, Spain
    • Hospital Universitario La Paz
  • Madrid, Spain
    • Hospital Universitario Ramon Y Cajal
  • Madrid, Spain
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain
    • Hospital Universitario la Zarzuela
  • Madrid, Spain
    • Hospital Central de la Defensa Gómez Ulla
  • Madrid, Spain
    • GenesisCare Madrid Hospital La Milagrosa
  • Murcia, Spain
    • Hospital General Universitario Morales Meseguer
  • Málaga, Spain
    • Hospital Regional Universitario
  • Palma De Mallorca, Spain
    • Hospital Universitari Son Espases
  • Santa Cruz De Tenerife, Spain
    • Hospital Universitario Nuestra Señora de Candelaria
  • Tarragona, Spain
    • Hospital de Sant Pau i Santa Tecla
  • Toledo, Spain, 45007
    • Hospital Universitario de Toledo
  • Valencia, Spain
    • Hospital Arnau de Vilanova
  • Valencia, Spain
    • Fundacion Instituto Valenciano de Oncologia
  • Valencia, Spain
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain
    • Hospital Universitario La Fe
  • Valencia, Spain
    • Hospital General Universitario de Valencia
  • Valladolid, Spain
    • Hospital Universitario Río Hortega
  • Zaragoza, Spain
    • Hospital Clinico Universitario Lozano Blesa
  • Zaragoza, Spain
    • Hospital Quirón Zaragoza
  • A Coruña
    • Ferrol, A Coruña, Spain
      • Complejo Hospitalario Universitario de Ferrol
  • Alicante
    • Alcoy, Alicante, Spain
      • Hospital Virgen de los Lirios
  • Asturias
    • Avilés, Asturias, Spain
      • Hospital Universitario San Agustín
  • Barcelona
    • Granollers, Barcelona, Spain
      • Hospital General de Granollers
    • L'Hospitalet De Llobregat, Barcelona, Spain
      • Instituto Catalán de Oncología de L'Hospitalet
    • Sabadell, Barcelona, Spain
      • Consorci Corporació Sànitari Parc Taulí
    • Terrassa, Barcelona, Spain
      • Consorci Sanitari de Terrassa
  • Bizcaia
    • Bilbao, Bizcaia, Spain
      • Hospital Universitario Basurto
  • Castellón
    • Castellón De La Plana, Castellón, Spain
      • Consorcio Hospitalario Provincial de Castellón
  • Ciudad Real
    • Alcázar De San Juan, Ciudad Real, Spain
      • Hospital General La Mancha Centro
  • Guipúzcoa
    • Donostia-San Sebastián, Guipúzcoa, Spain
      • Hospital Universitario Donostia
    • Donostia-San Sebastián, Guipúzcoa, Spain
      • Onkologikoa
  • Madrid
    • Fuenlabrada, Madrid, Spain
      • Hospital Universitario de Fuenlabrada
    • Getafe, Madrid, Spain
      • Hospital Universitario de Getafe
    • Leganés, Madrid, Spain
      • Hospital Universitario Severo Ochoa
    • Móstoles, Madrid, Spain
      • Hospital Universitario de Móstoles
    • Pozuelo De Alarcón, Madrid, Spain
      • Hospital Universitario Quirónsalud Madrid
  • Murcia
    • El Palmar, Murcia, Spain
      • Hospital Clínico Universitario Virgen de la Arrixaca
  • Navarra
    • Pamplona, Navarra, Spain
      • Clinica Universidad de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain
      • Hospital Álvaro Cunqueiro
  • Tarragona
    • Tortosa, Tarragona, Spain
      • Hospital de Tortosa Verge de la Cinta
  • Álava
    • Vitoria-Gasteiz, Álava, Spain
      • Hospital Universitario de Araba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological and molecular characteristics analyzed in primary tumors: tumor subtypes	Number of Participants With tumor subtypes, luminal profiles (e.g., luminal subtypes M1/M2, intrinsic subtypes)	From date of patient breast cancer diagnosis until 2019.
Biological and molecular characteristics analyzed in primary tumors: risk groups	Number of Participants With risk groups on the reference of breast cancer in women, including morphological analyses and description of the clinical profile (e.g., morphological type, differentiation (histologic grade), Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal growth factor Receptor 2 (HER2), Androgen Receptor (AR), Ki-67).	From date of patient breast cancer diagnosis until 2019.
Date and cause of death	Date and cause of death, when applicable.	From date of patient breast cancer diagnosis until 2019.
Disease-free survival (DFS).	DFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented relapse event (local, regional and/or distant) of the disease, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.	From date of patient breast cancer diagnosis until 2019.
Distant metastasis-free survival (DMFS).	DMFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented distant relapse, second invasive non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.	From date of patient breast cancer diagnosis until 2019.
Progression-free survival (PFS).	PFS: it is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.	From date of patient breast cancer diagnosis until 2019.
Overall survival (OS).	OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause.	From date of patient breast cancer diagnosis until 2019.

Collaborators and Investigators

• Sponsor: Spanish Breast Cancer Research Group
• Collaborators: Fundación ADEY
• Investigators: Study Director: Chief Medical Investigator, Hospital Universitario Ramon y Cajal, Madrid, Spain; Study Director: Chief Medical Investigator, Fundación Onkologikoa, San Sebastián, Spain

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 11, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Observational; Breast Cancer in males; Gene Sequencing
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Breast Neoplasms, Male
• Other Study ID Numbers: GEICAM/2016-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No