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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03800355
Other study ID # GEICAM/2016-04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 14, 2018
Est. completion date March 31, 2023

Study information

Verified date January 2024
Source Spanish Breast Cancer Research Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 777
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Spain Complejo Hospitalario Universitario A Coruña A Coruña
Spain Hospital General La Mancha Centro Alcázar De San Juan Ciudad Real
Spain Hospital Virgen de los Lirios Alcoy Alicante
Spain Hospital Universitario San Agustín Avilés Asturias
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 Universitario Basurto Bilbao Bizcaia
Spain Consorcio Hospitalario Provincial de Castellón Castellón De La Plana Castellón
Spain Hospital Virgen de la Luz Cuenca
Spain Hospital Universitario Donostia Donostia-San Sebastián Guipúzcoa
Spain Onkologikoa Donostia-San Sebastián Guipúzcoa
Spain Hospital Clínico Universitario Virgen de la Arrixaca El Palmar Murcia
Spain Complejo Hospitalario Universitario de Ferrol Ferrol A Coruña
Spain Hospital Universitario de Fuenlabrada Fuenlabrada Madrid
Spain Hospital Universitario de Getafe Getafe Madrid
Spain Instituto Catalán de Oncología de Girona Girona
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Hospital General de Granollers Granollers Barcelona
Spain Hospital Juan Ramón Jiménez Huelva
Spain Complejo Hospitalario de Jaén Jaén
Spain Instituto Catalán de Oncología de L'Hospitalet L'Hospitalet De Llobregat Barcelona
Spain Complejo Hospitalario Universitario Insular-Materno Infantil Las Palmas De Gran Canaria
Spain Hospital Universitario Severo Ochoa Leganés Madrid
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 Universitario de Móstoles Móstoles Madrid
Spain Hospital General Universitario Morales Meseguer Murcia
Spain Hospital Universitari Son Espases Palma De Mallorca
Spain Clínica Universidad de Navarra Pamplona Navarra
Spain Hospital Universitario Quirónsalud Madrid Pozuelo De Alarcón Madrid
Spain Consorci Corporació Sànitari Parc Taulí Sabadell Barcelona
Spain Hospital Universitario Nuestra Señora De Candelaria Santa Cruz De Tenerife
Spain Hospital de Sant Pau i Santa Tecla Tarragona
Spain Consorci Sanitari de Terrassa Terrassa Barcelona
Spain Hospital Universitario de Toledo Toledo
Spain Hospital de Tortosa Verge de la Cinta Tortosa Tarragona
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 Álvaro Cunqueiro Vigo Pontevedra
Spain Hospital Universitario de Araba Vitoria-Gasteiz Álava
Spain Hospital Clínico Universitario Lozano Blesa Zaragoza
Spain Hospital Quirón Zaragoza Zaragoza

Sponsors (2)

Lead Sponsor Collaborator
Spanish Breast Cancer Research Group Fundación ADEY

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary General condition: Age General condition age will be recorded. From date of patient breast cancer diagnosis until 2019.
Primary General condition: performance status at diagnosis Performance status by Eastern Cooperative Oncology Group (ECOG) Scale From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary 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.
Primary 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 Primary comorbidities Primary comorbidities will be recorded. From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary Family history of cancer Family history of cancer will be recorded. From date of patient breast cancer diagnosis until 2019.
Primary Anatomopathological characteristics of the tumor: date of diagnosis Date of diagnosis will be collected. From date of patient breast cancer diagnosis until 2019.
Primary Anatomopathological characteristics of the tumor: histology The histology of the tumor will be collected From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary Anatomopathological characteristics of the tumor: hormone-receptor expression Hormone-receptor expression will be collected From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary Anatomopathological characteristics of the tumor: histologic grade Tumor histologic grade will be collected From date of patient breast cancer diagnosis until 2019.
Primary Anatomopathological characteristics of the tumor: Ki-67 Tumor Ki-67 proliferation index will be collected From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary Treatment data: date of surgery Will be collected date of surgery From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary Treatment data: type of chemotherapy Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy. From date of patient breast cancer diagnosis until 2019.
Primary Treatment data: adjuvant radiotherapy Number of Participants With adjuvant radiotherapy From date of patient breast cancer diagnosis until 2019.
Primary Treatment data: adjuvant hormonotherapy Number of Participants With hormonotherapy From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary 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.
Primary Follow-up data: site of metastatic disease Number of Participants With site of metastatic disease From date of patient breast cancer diagnosis until 2019.
Primary 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.
Primary 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 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.
Secondary 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.
Secondary Date and cause of death Date and cause of death, when applicable. From date of patient breast cancer diagnosis until 2019.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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