Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk
- Conditions
- Breast Cancer, Male
- Registration Number
- NCT03800355
- Lead Sponsor
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 777
- 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.
- Male patients who do not wish to participate in the study for any reason.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body mass index (BMI) 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.
General condition: performance status at diagnosis From date of patient breast cancer diagnosis until 2019. Performance status by Eastern Cooperative Oncology Group (ECOG) Scale
Treatment data: other type of anti-cancer treatment From date of patient breast cancer diagnosis until 2019. Number of Participants With other type of anti-cancer treatment.
Follow-up data: occurrence of other primary tumors 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 From date of patient breast cancer diagnosis until 2019. The date of the last review and current clinical condition will be recorded.
General condition: Age From date of patient breast cancer diagnosis until 2019. General condition age will be recorded.
Anatomopathological characteristics of the tumor: hormone-receptor expression From date of patient breast cancer diagnosis until 2019. Hormone-receptor expression will be collected
Anatomopathological characteristics of the tumor: histologic grade From date of patient breast cancer diagnosis until 2019. Tumor histologic grade will be collected
Treatment data: type of surgery 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: adjuvant radiotherapy From date of patient breast cancer diagnosis until 2019. Number of Participants With adjuvant radiotherapy
Anatomopathological characteristics of the tumor: histology From date of patient breast cancer diagnosis until 2019. The histology of the tumor will be collected
Primary comorbidities 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 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 From date of patient breast cancer diagnosis until 2019. Family history of cancer will be recorded.
Anatomopathological characteristics of the tumor: clinical and/or pathological stage 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: Human Epidermal Growth Factor Receptor 2 (HER-2) expression 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: Ki-67 From date of patient breast cancer diagnosis until 2019. Tumor Ki-67 proliferation index will be collected
Treatment data: date of surgery From date of patient breast cancer diagnosis until 2019. Will be collected date of surgery
General condition and history: substance abuse 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 From date of patient breast cancer diagnosis until 2019. Diagnosis of other primary tumors synchronous or metachronous, will be recorded.
Anatomopathological characteristics of the tumor: date of diagnosis From date of patient breast cancer diagnosis until 2019. Date of diagnosis will be collected.
Treatment data: type of chemotherapy From date of patient breast cancer diagnosis until 2019. Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.
Treatment data: adjuvant hormonotherapy From date of patient breast cancer diagnosis until 2019. Number of Participants With hormonotherapy
Follow-up data: relapse type From date of patient breast cancer diagnosis until 2019. Number of Participants With each relapse type: local, regional or distant
Anatomopathological characteristics of the tumor: lymphovascular invasion From date of patient breast cancer diagnosis until 2017. Number of Participants With Presence of lymphovascular invasion will be collected
Follow-up data: site of metastatic disease From date of patient breast cancer diagnosis until 2019. Number of Participants With site of metastatic disease
- Secondary Outcome Measures
Name Time Method Date and cause of death From date of patient breast cancer diagnosis until 2019. Date and cause of death, when applicable.
Biological and molecular characteristics analyzed in primary tumors: tumor subtypes 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)
Biological and molecular characteristics analyzed in primary tumors: risk groups 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).
Disease-free survival (DFS). 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.
Distant metastasis-free survival (DMFS). 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.
Progression-free survival (PFS). 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.
Overall survival (OS). 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.
Trial Locations
- Locations (54)
Hospital Universitario de Móstoles
🇪🇸Móstoles, Madrid, Spain
Hospital Universitario Donostia
🇪🇸Donostia-San Sebastián, Guipúzcoa, Spain
Hospital Universitario Quirónsalud Madrid
🇪🇸Pozuelo De Alarcón, Madrid, Spain
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital General de Granollers
🇪🇸Granollers, Barcelona, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Fuenlabrada, Madrid, Spain
Onkologikoa
🇪🇸Donostia-San Sebastián, Guipúzcoa, Spain
Hospital Virgen de la Luz
🇪🇸Cuenca, Spain
Hospital Regional Universitario
🇪🇸Málaga, Spain
Hospital Universitario de Getafe
🇪🇸Getafe, Madrid, Spain
Hospital Universitari Vall D´Hebrón
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario de Ferrol
🇪🇸Ferrol, A Coruña, Spain
Consorci Sanitari de Terrassa
🇪🇸Terrassa, Barcelona, Spain
Hospital Virgen de los Lirios
🇪🇸Alcoy, Alicante, Spain
Hospital de Tortosa Verge de la Cinta
🇪🇸Tortosa, Tarragona, Spain
Hospital General La Mancha Centro
🇪🇸Alcázar De San Juan, Ciudad Real, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Instituto Catalán de Oncología de L'Hospitalet
🇪🇸L'Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitario Basurto
🇪🇸Bilbao, Bizcaia, Spain
Consorcio Hospitalario Provincial de Castellón
🇪🇸Castellón De La Plana, Castellón, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸El Palmar, Murcia, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario San Agustín
🇪🇸Avilés, Asturias, Spain
Consorci Corporació Sànitari Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
IDOC Centre Médic
🇪🇸Barcelona, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Fundación Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Complejo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Juan Ramón Jiménez
🇪🇸Huelva, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario Nuestra Señora De Candelaria
🇪🇸Santa Cruz De Tenerife, Spain
GenesisCare Madrid Hospital La Milagrosa
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Instituto Catalán de Oncología de Girona
🇪🇸Girona, Spain
Hospital Central de la Defensa Gómez Ulla
🇪🇸Madrid, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Universitario de Toledo
🇪🇸Toledo, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Universitario de Araba
🇪🇸Vitoria-Gasteiz, Álava, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Spain
Hospital de Sant Pau i Santa Tecla
🇪🇸Tarragona, Spain
Hospital Quirón Zaragoza
🇪🇸Zaragoza, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitario La Zarzuela
🇪🇸Madrid, Spain
Hospital Universitari Son Espases
🇪🇸Palma De Mallorca, Spain
Hospital Universitario Río Hortega
🇪🇸Valladolid, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Universitari Dexeus-Grupo Quirónsalud-Instituto Oncológico Dr. Rosell
🇪🇸Barcelona, Spain