An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 777
- 试验地点
- 54
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Male patients who do not wish to participate in the study for any reason.
结局指标
主要结局
Body mass index (BMI)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From date of patient breast cancer diagnosis until 2019.
General condition age will be recorded.
Anatomopathological characteristics of the tumor: hormone-receptor expression
时间窗: From date of patient breast cancer diagnosis until 2019.
Hormone-receptor expression will be collected
Anatomopathological characteristics of the tumor: histologic grade
时间窗: From date of patient breast cancer diagnosis until 2019.
Tumor histologic grade will be collected
Treatment data: type of surgery
时间窗: 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
时间窗: From date of patient breast cancer diagnosis until 2019.
Number of Participants With adjuvant radiotherapy
Primary comorbidities
时间窗: 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
时间窗: 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
时间窗: From date of patient breast cancer diagnosis until 2019.
Family history of cancer will be recorded.
Anatomopathological characteristics of the tumor: histology
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: From date of patient breast cancer diagnosis until 2019.
Tumor Ki-67 proliferation index will be collected
Treatment data: date of surgery
时间窗: From date of patient breast cancer diagnosis until 2019.
Will be collected date of surgery
General condition and history: substance abuse
时间窗: 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
时间窗: 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
时间窗: From date of patient breast cancer diagnosis until 2019.
Date of diagnosis will be collected.
Treatment data: type of chemotherapy
时间窗: From date of patient breast cancer diagnosis until 2019.
Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.
Treatment data: adjuvant hormonotherapy
时间窗: From date of patient breast cancer diagnosis until 2019.
Number of Participants With hormonotherapy
Follow-up data: relapse type
时间窗: 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
时间窗: 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
时间窗: From date of patient breast cancer diagnosis until 2019.
Number of Participants With site of metastatic disease
次要结局
- Date and cause of death(From date of patient breast cancer diagnosis until 2019.)
- Biological and molecular characteristics analyzed in primary tumors: tumor subtypes(From date of patient breast cancer diagnosis until 2019.)
- Biological and molecular characteristics analyzed in primary tumors: risk groups(From date of patient breast cancer diagnosis until 2019.)
- Disease-free survival (DFS).(From date of patient breast cancer diagnosis until 2019.)
- Distant metastasis-free survival (DMFS).(From date of patient breast cancer diagnosis until 2019.)
- Progression-free survival (PFS).(From date of patient breast cancer diagnosis until 2019.)
- Overall survival (OS).(From date of patient breast cancer diagnosis until 2019.)