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

• ClinicalTrials.gov Identifier: NCT03800355
• Recruitment Status: Active, not recruiting
• First Posted: January 11, 2019
• Last Update Posted: April 18, 2023
• Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Fundación ADEY
• Information provided by (Responsible Party): Spanish Breast Cancer Research Group

Study Description

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).

Condition or disease
Breast Cancer, Male

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

• Study Type: Observational
• Actual Enrollment: 777 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
• Actual Study Start Date: September 14, 2018
• Estimated Primary Completion Date: October 30, 2023
• Estimated Study Completion Date: December 31, 2024

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Biospecimen Retention:   Samples With DNA

Tumor tissue and blood samples will be collected and biological and genetic analyses will be performed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

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.

Criteria

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.

Contacts and Locations

Locations

Spain

Complejo Hospitalario Universitario de Ferrol

Ferrol, A Coruña, Spain

Hospital Virgen de los Lirios

Alcoy, Alicante, Spain

Hospital Universitario San Agustín

Avilés, Asturias, 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

Castellón De La Plana, Castellón, Spain

Hospital General La Mancha Centro

Alcázar De San Juan, Ciudad Real, Spain

Hospital Universitario Donostia

Donostia-San Sebastián, Guipúzcoa, Spain

Onkologikoa

Donostia-San Sebastián, Guipúzcoa, Spain

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Hospital Universitario de Móstoles

Móstoles, Madrid, Spain

Hospital Universitario Quirónsalud Madrid

Pozuelo De Alarcón, Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Clínica Universidad de Navarra

Pamplona, Navarra, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital de Tortosa Verge de la Cinta

Tortosa, Tarragona, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell

Barcelona, Spain

Hospital Universitari Vall D´Hebrón

Barcelona, Spain

IDOC Centre Médic

Barcelona, Spain

Hospital Virgen de la Luz

Cuenca, Spain

Instituto Catalán de Oncología de Girona

Girona, Spain

Hospital Universitario Virgen de las Nieves

Granada, Spain

Hospital Juan Ramón Jiménez

Huelva, Spain

Complejo Hospitalario de Jaén

Jaén, Spain

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas De Gran Canaria, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

GenesisCare Madrid Hospital La Milagrosa

Madrid, Spain

Hospital Central de la Defensa Gómez Ulla

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario La Zarzuela

Madrid, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital General Universitario Morales Meseguer

Murcia, Spain

Hospital Regional Universitario

Málaga, Spain

Hospital Universitari Son Espases

Palma De Mallorca, Spain

Hospital Universitario Nuestra Señora De Candelaria

Santa Cruz De Tenerife, Spain

Hospital de Sant Pau i Santa Tecla

Tarragona, Spain

Hospital Universitario de Toledo

Toledo, Spain, 45007

Fundación Instituto Valenciano de Oncología

Valencia, Spain

Hospital Arnau de Vilanova

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital Universitario La Fe

Valencia, Spain

Hospital Universitario Río Hortega

Valladolid, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

Hospital Quirón Zaragoza

Zaragoza, Spain

Hospital Universitario de Araba

Vitoria-Gasteiz, Álava, Spain

Sponsors and Collaborators

Spanish Breast Cancer Research Group

Fundación ADEY

Investigators

• Study Director: Chief Medical Investigator; Hospital Universitario Ramón y Cajal, Madrid, Spain
• Study Director: Chief Medical Investigator; Fundación Onkologikoa, San Sebastián, Spain

More Information

Additional Information:

Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group 

• Responsible Party: Spanish Breast Cancer Research Group
• ClinicalTrials.gov Identifier: NCT03800355
• Other Study ID Numbers: GEICAM/2016-04
• First Posted: January 11, 2019
• Last Update Posted: April 18, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Spanish Breast Cancer Research Group:

Breast Cancer in males; Observational; Gene Sequencing

Additional relevant MeSH terms:

Breast Neoplasms; Breast Neoplasms, Male; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases