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

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ClinicalTrials.gov Identifier: NCT03800355
Recruitment Status : Enrolling by invitation
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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 2017 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 2017.

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Study Type : Observational
Estimated Enrollment : 1000 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 : September 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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 2017, and treated in the Medical Oncology Departments of participating sites.



Primary Outcome Measures :
  1. General condition: Age [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    General condition age will be recorded.

  2. General condition: performance status at diagnosis [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    Date of diagnosis will be collected.

  10. Anatomopathological characteristics of the tumor: histology [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    Tumor histologic grade will be collected

  15. Anatomopathological characteristics of the tumor: Ki-67 [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    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 2017. ]
    Will be collected date of surgery

  18. Treatment data: type of surgery [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    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 2017. ]
    Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.

  20. Treatment data: adjuvant radiotherapy [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Number of Participants With adjuvant radiotherapy

  21. Treatment data: adjuvant hormonotherapy [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Number of Participants With hormonotherapy

  22. Treatment data: other type of anti-cancer treatment [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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), HER2, Androgen Receptor (AR), Ki-67).

  3. Date and cause of death [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Date and cause of death, when applicable.

  4. Disease-free survival (DFS). [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    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 samples will be collected and biological and genetic analyses will be performed.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 2017, and treated in the Medical Oncology Departments of participating sites.
Criteria

Inclusion Criteria:

  • Male patients diagnosed with primary invasive breast carcinoma between the years 2000-2017, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800355


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Locations
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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 Marqués de Valdecilla
Santander, Cantabria, 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
Complejo Hospitalario 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 Clínic de Barcelona
Barcelona, 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
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
Complejo Hospitalario de Pontevedra
Pontevedra, Spain
Hospital Universitario Nuestra Señora De Candelaria
Santa Cruz De Tenerife, Spain
Hospital de Sant Pau i Santa Tecla
Tarragona, Spain
Hospital Virgen de la Salud
Toledo, Spain
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 Universitari i Politécnic La Fe
Valencia, Spain
Hospital Universitario Río Hortega
Valladolid, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Universitario de Araba
Vitoria-Gasteiz, Álava, Spain
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Investigators
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Study Director: Chief Medical Investigator Hospital Universitario Ramón y Cajal, Madrid, Spain
Study Director: Chief Medical Investigator Fundación Onkologikoa, San Sebastián, Spain

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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT03800355     History of Changes
Other Study ID Numbers: GEICAM/2016-04
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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