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Completed

NCT Number: NCT03800355

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Complejo Hospitalario Universitario de Ferrol, Ferrol, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. General condition: Age

    Time frame: From date of patient breast cancer diagnosis until 2019.

    General condition age will be recorded.

  2. General condition: performance status at diagnosis

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Performance status by Eastern Cooperative Oncology Group (ECOG) Scale

  3. General condition and history: substance abuse

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Number of Participants With Substance abuse of tobacco and alcohol will be recorded.

  4. Diagnosis of other primary tumors

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Diagnosis of other primary tumors synchronous or metachronous, will be recorded.

  5. Body mass index (BMI)

    Time frame: 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.

  6. Primary comorbidities

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Primary comorbidities will be recorded.

  7. Mutational status of BReast CAncer gene (BRCA) or other genes of genetic predisposition

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Mutational status of BRCA or other genes of genetic predisposition will be recorded.

  8. Family history of cancer

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Family history of cancer will be recorded.

  9. Anatomopathological characteristics of the tumor: date of diagnosis

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Date of diagnosis will be collected.

  10. Anatomopathological characteristics of the tumor: histology

    Time frame: From date of patient breast cancer diagnosis until 2019.

    The histology of the tumor will be collected

  11. Anatomopathological characteristics of the tumor: clinical and/or pathological stage

    Time frame: 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).

  12. Anatomopathological characteristics of the tumor: hormone-receptor expression

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Hormone-receptor expression will be collected

  13. Anatomopathological characteristics of the tumor: Human Epidermal Growth Factor Receptor 2 (HER-2) expression

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected

  14. Anatomopathological characteristics of the tumor: histologic grade

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Tumor histologic grade will be collected

  15. Anatomopathological characteristics of the tumor: Ki-67

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Tumor Ki-67 proliferation index will be collected

  16. Anatomopathological characteristics of the tumor: lymphovascular invasion

    Time frame: From date of patient breast cancer diagnosis until 2017.

    Number of Participants With Presence of lymphovascular invasion will be collected

  17. Treatment data: date of surgery

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Will be collected date of surgery

  18. Treatment data: type of surgery

    Time frame: 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.

  19. Treatment data: type of chemotherapy

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.

  20. Treatment data: adjuvant radiotherapy

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Number of Participants With adjuvant radiotherapy

  21. Treatment data: adjuvant hormonotherapy

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Number of Participants With hormonotherapy

  22. Treatment data: other type of anti-cancer treatment

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Number of Participants With other type of anti-cancer treatment.

  23. Follow-up data: relapse type

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Number of Participants With each relapse type: local, regional or distant

  24. Follow-up data: site of metastatic disease

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Number of Participants With site of metastatic disease

  25. Follow-up data: occurrence of other primary tumors

    Time frame: 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).

  26. Follow-up data: current condition

    Time frame: From date of patient breast cancer diagnosis until 2019.

    The date of the last review and current clinical condition will be recorded.

Secondary outcomes

  1. Biological and molecular characteristics analyzed in primary tumors: tumor subtypes

    Time frame: 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)

  2. Biological and molecular characteristics analyzed in primary tumors: risk groups

    Time frame: 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).

  3. Date and cause of death

    Time frame: From date of patient breast cancer diagnosis until 2019.

    Date and cause of death, when applicable.

  4. Disease-free survival (DFS).

    Time frame: 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.

  5. Distant metastasis-free survival (DMFS).

    Time frame: 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.

  6. Progression-free survival (PFS).

    Time frame: 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.

  7. Overall survival (OS).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Spanish Breast Cancer Research Group

Other

Collaborators

  • Fundación ADEY

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Jan 11, 2019
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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