The Characteristics, Treatment Patterns and Prognosis of Chinese Male Breast Cancer: A Real-world Study

The goal of this observational study is to investigate the features in Chinese male breast cancer (MBC) patients. The main question it aims to answer is:

• The characteristics, treatment patterns and prognosis of Chinese MBC patients. The clinicopathological characteristics, treatment information and follow-up data of participants will be extracted from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved Chinese centers.

Researchers will investigate the features, survival associated factors and other relevant factors of this population.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Breast cancer

Detailed Description

The goal of this observational study is to investigate the features in Chinese male breast cancer (MBC) patients. The main question it aims to answer is:

• The characteristics, treatment patterns and prognosis of Chinese MBC patients. The clinicopathological characteristics, treatment information and follow-up data of participants will be extracted from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved Chinese centers.

Researchers will investigate the features, survival associated factors and other relevant factors of this population.

The collected variables included: survival time, survival status, year of diagnosis, age, stage, molecular subtype statuses, histology, grade, and surgery, radiotherapy and systemic therapies utilization.

• Study Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Yuxuan Gao, MD; Phone Number: +86 18142846375; Email: gaoyx9@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Recruiting
      • First Affiliated Hospital of Sun Yat-sen University
      • Contact: Yuxuan Gao, MD; Phone Number: +8618142846375; Email: gaoyx9@mail2.sysu.edu.cn
      • Principal Investigator: Ying Lin, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All eligible cases were collected from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved centers.

Description

Inclusion Criteria:

• Biological sex is male;
• Microscopically diagnosed as primary breast cancer.

Exclusion Criteria:

• Presence of skin-origin malignancy on the breast.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chinese; About 1,200 Chinese male breast cancer cases are anticipated to collected retrospectively. The clinicopathological characteristics, treatment and survival information are retrospectively collected.	Other: Breast cancer; Male patients who were microscopically diagnosed as primary breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The duration between the date of the first pathologic diagnosis and death from any cause or last follow-up.	From the time of diagnosis to August 1, 2024 (anticipated).

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Peking University First Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Sun Yat-sen University; Beijing 302 Hospital; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; Guangdong Provincial People's Hospital; First People's Hospital of Foshan; The Affiliated Hospital Of Guizhou Medical University; First Hospital of China Medical University; Peking University Shenzhen Hospital; The Second Affiliated Hospital of Harbin Medical University; The Fourth Hospital of Hebei Medical University; Shantou Central Hospital; Fujian Provincial Hospital; Guangdong Women and Children Hospital; The Affiliated Cancer Hospital of Zhengzhou University; Jiangmen Central Hospital; Jieyang People's Hospital; Beijing Medical Award Foundation; The Affiliated Cancer Hospital of Xinjiang Medical University; The Third Affiliated Hospital of Kunming Medical University; The Third Hospital of Nanchang City; The Second Affiliated Hospital, Guangzhou Medical University; The First Affiliated Hospital, Zhejiang University; Affiliated Sanming First Hospital of Fujian Medical University; National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital; Lianjiang Pepole's Hospital, Lianjiang; Zhanjiang Central Hospital; Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
• Investigators: Principal Investigator: Ying Lin, MD, PhD, 1st affiliated hospital of Sun Yat-sen university

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: January 13, 2024
• First Posted (Estimated): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 13, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Breast Neoplasms, Male
• Other Study ID Numbers: 2021[516]

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A part of Chinese data that support the findings of this study are available from Chinese Society of Clinical Oncology Breast Cancer Database but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Chinese data are however available from the corresponding author upon reasonable request and with permission of Chinese Society of Clinical Oncology Breast Cancer Database.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No