Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing

Conditions
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Breast Cancer, Male

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male breast cancer<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer in males, Observational, Gene Sequencing