Breast Cancer, Male
Conditions
Keywords
Breast Cancer in males, Observational, Gene Sequencing
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.
Interventions
None listed
Sponsors
Fundación ADEY
Spanish Breast Cancer Research Group
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up data: current condition | From date of patient breast cancer diagnosis until 2019. | The date of the last review and current clinical condition will be recorded. |
| Treatment data: type of chemotherapy | From date of patient breast cancer diagnosis until 2019. | Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy. |
| Treatment data: adjuvant radiotherapy | From date of patient breast cancer diagnosis until 2019. | Number of Participants With adjuvant radiotherapy |
| Treatment data: adjuvant hormonotherapy | From date of patient breast cancer diagnosis until 2019. | Number of Participants With hormonotherapy |
| Treatment data: other type of anti-cancer treatment | From date of patient breast cancer diagnosis until 2019. | Number of Participants With other type of anti-cancer treatment. |
| Follow-up data: relapse type | From date of patient breast cancer diagnosis until 2019. | Number of Participants With each relapse type: local, regional or distant |
| Follow-up data: site of metastatic disease | From date of patient breast cancer diagnosis until 2019. | Number of Participants With site of metastatic disease |
| Follow-up data: occurrence of other primary tumors | From date of patient breast cancer diagnosis until 2019. | Number of Participants With occurrence of other primary tumors whether or not of breast origin (in situ or invasive). |
| Body mass index (BMI) | From date of patient breast cancer diagnosis until 2019. | 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. |
| General condition: Age | From date of patient breast cancer diagnosis until 2019. | General condition age will be recorded. |
| General condition: performance status at diagnosis | From date of patient breast cancer diagnosis until 2019. | Performance status by Eastern Cooperative Oncology Group (ECOG) Scale |
| General condition and history: substance abuse | From date of patient breast cancer diagnosis until 2019. | Number of Participants With Substance abuse of tobacco and alcohol will be recorded. |
| Diagnosis of other primary tumors | From date of patient breast cancer diagnosis until 2019. | Diagnosis of other primary tumors synchronous or metachronous, will be recorded. |
| Primary comorbidities | From date of patient breast cancer diagnosis until 2019. | Primary comorbidities will be recorded. |
| Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition | From date of patient breast cancer diagnosis until 2019. | Mutational status of BRCA or other genes of genetic predisposition will be recorded. |
| Family history of cancer | From date of patient breast cancer diagnosis until 2019. | Family history of cancer will be recorded. |
| Anatomopathological characteristics of the tumor: date of diagnosis | From date of patient breast cancer diagnosis until 2019. | Date of diagnosis will be collected. |
| Anatomopathological characteristics of the tumor: histology | From date of patient breast cancer diagnosis until 2019. | The histology of the tumor will be collected |
| Anatomopathological characteristics of the tumor: clinical and/or pathological stage | From date of patient breast cancer diagnosis until 2019. | 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). |
| Anatomopathological characteristics of the tumor: hormone-receptor expression | From date of patient breast cancer diagnosis until 2019. | Hormone-receptor expression will be collected |
| Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression | From date of patient breast cancer diagnosis until 2019. | Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected |
| Anatomopathological characteristics of the tumor: histologic grade | From date of patient breast cancer diagnosis until 2019. | Tumor histologic grade will be collected |
| Anatomopathological characteristics of the tumor: Ki-67 | From date of patient breast cancer diagnosis until 2019. | Tumor Ki-67 proliferation index will be collected |
| Anatomopathological characteristics of the tumor: lymphovascular invasion | From date of patient breast cancer diagnosis until 2017. | Number of Participants With Presence of lymphovascular invasion will be collected |
| Treatment data: date of surgery | From date of patient breast cancer diagnosis until 2019. | Will be collected date of surgery |
| Treatment data: type of surgery | From date of patient breast cancer diagnosis until 2019. | Number of participants with each type of surgery: mastectomy or lumpectomy or quadrantectomy or lymphadenectomy or sentinel lymph node biopsy will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological and molecular characteristics analyzed in primary tumors: risk groups | From date of patient breast cancer diagnosis until 2019. | 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). |
| Date and cause of death | From date of patient breast cancer diagnosis until 2019. | Date and cause of death, when applicable. |
| Disease-free survival (DFS). | From date of patient breast cancer diagnosis until 2019. | 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. |
| Distant metastasis-free survival (DMFS). | From date of patient breast cancer diagnosis until 2019. | 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. |
| Progression-free survival (PFS). | From date of patient breast cancer diagnosis until 2019. | 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. |
| Overall survival (OS). | From date of patient breast cancer diagnosis until 2019. | OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause. |
| Biological and molecular characteristics analyzed in primary tumors: tumor subtypes | From date of patient breast cancer diagnosis until 2019. | Number of Participants With tumor subtypes, luminal profiles (e.g., luminal subtypes M1/M2, intrinsic subtypes) |
Countries
Spain
Outcome results
None listed