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).
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
777
General condition: Age
General condition age will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
General condition: performance status at diagnosis
Performance status by Eastern Cooperative Oncology Group (ECOG) Scale
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From date of patient breast cancer diagnosis until 2019.
Primary comorbidities
Primary comorbidities will be recorded.
Time frame: 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.
Time frame: From date of patient breast cancer diagnosis until 2019.
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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
...and 44 more locations
Family history of cancer
Family history of cancer will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: date of diagnosis
Date of diagnosis will be collected.
Time frame: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: histology
The histology of the tumor will be collected
Time frame: 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).
Time frame: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: hormone-receptor expression
Hormone-receptor expression will be collected
Time frame: 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
Time frame: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: histologic grade
Tumor histologic grade will be collected
Time frame: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: Ki-67
Tumor Ki-67 proliferation index will be collected
Time frame: 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
Time frame: From date of patient breast cancer diagnosis until 2017.
Treatment data: date of surgery
Will be collected date of surgery
Time frame: 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.
Time frame: From date of patient breast cancer diagnosis until 2019.
Treatment data: type of chemotherapy
Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.
Time frame: From date of patient breast cancer diagnosis until 2019.
Treatment data: adjuvant radiotherapy
Number of Participants With adjuvant radiotherapy
Time frame: From date of patient breast cancer diagnosis until 2019.
Treatment data: adjuvant hormonotherapy
Number of Participants With hormonotherapy
Time frame: 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.
Time frame: 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
Time frame: From date of patient breast cancer diagnosis until 2019.
Follow-up data: site of metastatic disease
Number of Participants With site of metastatic disease
Time frame: 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).
Time frame: 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.
Time frame: From date of patient breast cancer diagnosis until 2019.
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)
Time frame: 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).
Time frame: From date of patient breast cancer diagnosis until 2019.
Date and cause of death
Date and cause of death, when applicable.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From date of patient breast cancer diagnosis until 2019.