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出境医 / 临床实验 / Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk

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

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 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.
Study Design
Layout table for study information
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 : December 31, 2021
Estimated Study Completion Date : March 31, 2022
Arms and Interventions
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.
Outcome Measures
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), 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 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.

Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Study Project Manager 00 34 91 659 28 70 inicio_ensayos@geicam.org
Contact: Start-Up Unit Manager 00 34 91 659 28 70 inicio_ensayos@geicam.org

Locations
Show Show 54 study locations
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Investigators
Layout table for investigator information
Study Director: Chief Medical Investigator Hospital Universitario Ramón y Cajal, Madrid, Spain
Study Director: Chief Medical Investigator Fundación Onkologikoa, San Sebastián, Spain
Tracking Information
First Submitted Date June 22, 2018
First Posted Date January 11, 2019
Last Update Posted Date December 10, 2020
Actual Study Start Date September 14, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 8, 2019)
  • General condition: Age [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    General condition age will be recorded.
  • 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
  • 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.
  • 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.
  • 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.
  • Primary comorbidities [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    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 2017. ]
    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 2017. ]
    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 2017. ]
    Date of diagnosis will be collected.
  • 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
  • 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).
  • 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
  • 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
  • Anatomopathological characteristics of the tumor: histologic grade [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Tumor histologic grade will be collected
  • 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
  • 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 2017. ]
    Will be collected date of surgery
  • 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.
  • 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.
  • Treatment data: adjuvant radiotherapy [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Number of Participants With adjuvant radiotherapy
  • Treatment data: adjuvant hormonotherapy [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Number of Participants With hormonotherapy
  • 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.
  • 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
  • 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
  • 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).
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 3, 2019)
  • 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)
  • 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), Human Epidermal growth factor Receptor 2 (HER2), Androgen Receptor (AR), Ki-67).
  • Date and cause of death [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Date and cause of death, when applicable.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: January 8, 2019)
  • 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)
  • 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).
  • Date and cause of death [ Time Frame: From date of patient breast cancer diagnosis until 2017. ]
    Date and cause of death, when applicable.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk
Official Title An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
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).
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Tumor tissue samples will be collected and biological and genetic analyses will be performed.
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.
Condition Breast Cancer, Male
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 8, 2019)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Study Project Manager 00 34 91 659 28 70 inicio_ensayos@geicam.org
Contact: Start-Up Unit Manager 00 34 91 659 28 70 inicio_ensayos@geicam.org
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03800355
Other Study ID Numbers GEICAM/2016-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Spanish Breast Cancer Research Group
Study Sponsor Spanish Breast Cancer Research Group
Collaborators Not Provided
Investigators
Study Director: Chief Medical Investigator Hospital Universitario Ramón y Cajal, Madrid, Spain
Study Director: Chief Medical Investigator Fundación Onkologikoa, San Sebastián, Spain
PRS Account Spanish Breast Cancer Research Group
Verification Date December 2020

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