Breast Cancer, MaleNCT03800355
Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk
An observational study of Breast Cancer, Male, run by Spanish Breast Cancer Research Group at 54 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Breast Cancer, Male
- How many people
- 777 participants
- Where
- 54 sitesSpain
- Study dates
- 14 Sep 2018to 24 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Male patients who do not wish to participate in the study for any reason.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Spain54 sites
Complejo Hospitalario Universitario A Coruña
A Coruña
Hospital General La Mancha Centro
Alcázar de San Juan, Ciudad Real
Hospital Virgen de los Lirios
Alcoy, Alicante
Hospital Universitario San Agustín
Avilés, Principality of Asturias
Hospital del Mar
Barcelona
Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell
Barcelona
Hospital Universitari Vall D´Hebrón
Barcelona
IDOC Centre Médic
Barcelona
Hospital Universitario Basurto
Bilbao, Bizcaia
Consorcio Hospitalario Provincial de Castellón
Castellon, Castellón
Hospital Virgen de la Luz
Cuenca
Hospital Universitario Donostia
Donostia / San Sebastian, Guipúzcoa
Onkologikoa
Donostia / San Sebastian, Guipúzcoa
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid
Hospital Universitario de Getafe
Getafe, Madrid
Instituto Catalán de Oncología de Girona
Girona
Hospital Universitario Virgen de las Nieves
Granada
Hospital General de Granollers
Granollers, Barcelona
Hospital Juan Ramón Jiménez
Huelva
Complejo Hospitalario de Jaén
Jaén
Instituto Catalán de Oncología de L'Hospitalet
L'Hospitalet de Llobregat, Barcelona
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria
Hospital Universitario Severo Ochoa
Leganés, Madrid
Hospital Universitario Lucus Augusti
Lugo
GenesisCare Madrid Hospital La Milagrosa
Madrid
Hospital Central de la Defensa Gómez Ulla
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario La Zarzuela
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Regional Universitario
Málaga
Hospital Universitario de Móstoles
Móstoles, Madrid
Hospital General Universitario Morales Meseguer
Murcia
Hospital Universitari Son Espases
Palma de Mallorca
Clínica Universidad de Navarra
Pamplona, Navarre
Hospital Universitario Quirónsalud Madrid
Pozuelo de Alarcón, Madrid
Consorci Corporació Sànitari Parc Taulí
Sabadell, Barcelona
Hospital Universitario Nuestra Señora De Candelaria
Santa Cruz de Tenerife
Hospital de Sant Pau i Santa Tecla
Tarragona
Consorci Sanitari de Terrassa
Terrassa, Barcelona
Hospital Universitario de Toledo
Toledo, 45007
Hospital de Tortosa Verge de la Cinta
Tortosa, Tarragona
Fundación Instituto Valenciano de Oncología
Valencia
Hospital Arnau de Vilanova
Valencia
Hospital Clínico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Hospital Universitario La Fe
Valencia
Hospital Universitario Río Hortega
Valladolid
Hospital Álvaro Cunqueiro
Vigo, Pontevedra
Hospital Universitario de Araba
Vitoria-Gasteiz, Álava
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Quirón Zaragoza
Zaragoza
About this study
Official title: An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
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).
Read the 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.
- Conditions
- Breast Cancer, Male
- Keywords
- Breast Cancer in males, Observational, Gene Sequencing
- Medical subject headings
- Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Male breast cancer | 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 being measured
The primary outcome is the main question the study is designed to answer.
General condition: Age
General condition age will be recorded.
Measured: From date of patient breast cancer diagnosis until 2019.
General condition: performance status at diagnosis
Performance status by Eastern Cooperative Oncology Group (ECOG) Scale
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of patient breast cancer diagnosis until 2019.
Primary comorbidities
Primary comorbidities will be recorded.
Measured: 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.
Measured: From date of patient breast cancer diagnosis until 2019.
Family history of cancer
Family history of cancer will be recorded.
Measured: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: date of diagnosis
Date of diagnosis will be collected.
Measured: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: histology
The histology of the tumor will be collected
Measured: 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).
Measured: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: hormone-receptor expression
Hormone-receptor expression will be collected
Measured: 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
Measured: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: histologic grade
Tumor histologic grade will be collected
Measured: From date of patient breast cancer diagnosis until 2019.
Anatomopathological characteristics of the tumor: Ki-67
Tumor Ki-67 proliferation index will be collected
Measured: 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
Measured: From date of patient breast cancer diagnosis until 2017.
Treatment data: date of surgery
Will be collected date of surgery
Measured: 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.
Measured: From date of patient breast cancer diagnosis until 2019.
Treatment data: type of chemotherapy
Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.
Measured: From date of patient breast cancer diagnosis until 2019.
Treatment data: adjuvant radiotherapy
Number of Participants With adjuvant radiotherapy
Measured: From date of patient breast cancer diagnosis until 2019.
Treatment data: adjuvant hormonotherapy
Number of Participants With hormonotherapy
Measured: 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.
Measured: 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
Measured: From date of patient breast cancer diagnosis until 2019.
Follow-up data: site of metastatic disease
Number of Participants With site of metastatic disease
Measured: 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).
Measured: 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.
Measured: From date of patient breast cancer diagnosis until 2019.
Secondary outcomes (7)
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)
Measured: 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).
Measured: From date of patient breast cancer diagnosis until 2019.
Date and cause of death
Date and cause of death, when applicable.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of patient breast cancer diagnosis until 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start14 Sep 2018
- Primary completion31 Mar 2023
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Breast Cancer Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación ADEY
- Responsible party
- Sponsor
- Investigators
- Chief Medical Investigator, Study director, Hospital Universitario Ramón y Cajal, Madrid, SpainChief Medical Investigator, Study director, Fundación Onkologikoa, San Sebastián, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800355
- Sponsor's protocol ID
- GEICAM/2016-04
- Status last verified
- Feb 2025
- First submitted
- 22 Jun 2018
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
- ClinicalTrials.gov ID
- NCT03800355
- Acronym / sponsor ID
- GEICAM/2016-04
- Conditions
- Breast Cancer, Male
- Keywords
- Breast Cancer in males, Observational, Gene Sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 777 participants (actual)
- Lead sponsor
- Spanish Breast Cancer Research GroupUniversity, hospital or other
- Collaborators
- Fundación ADEY
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Male breast cancer | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Male patients who do not wish to participate in the study for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
General condition: Age
Time frame: From date of patient breast cancer diagnosis until 2019.
General condition age will be recorded.
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
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.
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.
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.
Primary comorbidities
Time frame: 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
Time frame: 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
Time frame: From date of patient breast cancer diagnosis until 2019.
Family history of cancer will be recorded.
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.
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
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).
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
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
Anatomopathological characteristics of the tumor: histologic grade
Time frame: From date of patient breast cancer diagnosis until 2019.
Tumor histologic grade will be collected
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
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
Treatment data: date of surgery
Time frame: From date of patient breast cancer diagnosis until 2019.
Will be collected date of surgery
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.
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.
Treatment data: adjuvant radiotherapy
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With adjuvant radiotherapy
Treatment data: adjuvant hormonotherapy
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With hormonotherapy
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.
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
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
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).
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.
7 secondary outcomes
Biological and molecular characteristics analyzed in primary tumors: tumor subtypes
Time frame: From date of patient breast cancer diagnosis until 2019.
Biological and molecular characteristics analyzed in primary tumors: risk groups
Time frame: From date of patient breast cancer diagnosis until 2019.
Date and cause of death
Time frame: From date of patient breast cancer diagnosis until 2019.
Disease-free survival (DFS).
Time frame: From date of patient breast cancer diagnosis until 2019.
Distant metastasis-free survival (DMFS).
Time frame: From date of patient breast cancer diagnosis until 2019.
Progression-free survival (PFS).
Time frame: From date of patient breast cancer diagnosis until 2019.
Overall survival (OS).
Time frame: From date of patient breast cancer diagnosis until 2019.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Investigator study director
Hospital Universitario Ramón y Cajal, Madrid, Spain
Chief Medical Investigator study director
Fundación Onkologikoa, San Sebastián, Spain
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, Male, run by Spanish Breast Cancer Research Group at 54 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General condition: Age (time frame: From date of patient breast cancer diagnosis until 2019.). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.