Breast CancerNCT06220630
The Characteristics, Treatment Patterns and Prognosis of Chinese Male Breast Cancer: A Real-world Study
An observational study of Breast Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast cancer
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All eligible cases were collected from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved centers.
Who may be able to join
- Biological sex is male;
- Microscopically diagnosed as primary breast cancer.
Who cannot join
- Presence of skin-origin malignancy on the breast.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Sun Yat-sen university
Guangzhou, Guangdong, 510030
Yuxuan Gao, MD, +8618142846375, gaoyx9@mail2.sysu.edu.cn
Ying Lin, MD, PhD
About this 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancerOther
Male patients who were microscopically diagnosed as primary breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Chinese | About 1,200 Chinese male breast cancer cases are anticipated to collected retrospectively. The clinicopathological characteristics, treatment and survival information are retrospectively collected. Receives: Other: Breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The duration between the date of the first pathologic diagnosis and death from any cause or last follow-up.
Measured: From the time of diagnosis to August 1, 2024 (anticipated).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Aug 2021
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Medical Award Foundation, The Affiliated Cancer Hospital of Xinjiang Medical University, Hebei Medical University Fourth Hospital, The Third Affiliated Hospital of Kunming Medical University, Sun Yat-sen University, Zhengzhou University, The Third Hospital of Nanchang City, Beijing 302 Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Fujian Provincial Hospital, First Hospital of China Medical University, The Affiliated Hospital of Qingdao University, Guangdong Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Foshan, Peking University First Hospital, The Affiliated Hospital Of Guizhou Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jiangmen Central Hospital, The Second Affiliated Hospital, Guangzhou Medical University, First Affiliated Hospital of Zhejiang University, Peking University Shenzhen Hospital, The Second Affiliated Hospital of Harbin Medical University, Affiliated Sanming First Hospital of Fujian Medical University, Jieyang People's Hospital, National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Shantou Central Hospital, The First Affiliated Hospital with Nanjing Medical University, Lianjiang Pepole's Hospital, Lianjiang, Guangdong Women and Children Hospital, Zhanjiang Central Hospital, Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Principal investigator, Ying Lin, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Ying Lin, MD, PhD, Principal investigator, 1st affiliated hospital of Sun Yat-sen university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220630
- Sponsor's protocol ID
- 2021[516]
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics, Treatment Patterns and Prognosis of Chinese Male Breast Cancer: A Real-world Study
- ClinicalTrials.gov ID
- NCT06220630
- Acronym / sponsor ID
- 2021[516]
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Beijing Medical Award Foundation, The Affiliated Cancer Hospital of Xinjiang Medical University, Hebei Medical University Fourth Hospital, The Third Affiliated Hospital of Kunming Medical University, Sun Yat-sen University, Zhengzhou University, The Third Hospital of Nanchang City, Beijing 302 Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Fujian Provincial Hospital, First Hospital of China Medical University, The Affiliated Hospital of Qingdao University, Guangdong Provincial People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Foshan, Peking University First Hospital, The Affiliated Hospital Of Guizhou Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jiangmen Central Hospital, The Second Affiliated Hospital, Guangzhou Medical University, First Affiliated Hospital of Zhejiang University, Peking University Shenzhen Hospital, The Second Affiliated Hospital of Harbin Medical University, Affiliated Sanming First Hospital of Fujian Medical University, Jieyang People's Hospital, National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Shantou Central Hospital, The First Affiliated Hospital with Nanjing Medical University, Lianjiang Pepole's Hospital, Lianjiang, Guangdong Women and Children Hospital, Zhanjiang Central Hospital, Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese | – | Other: Breast cancerAbout 1,200 Chinese male breast cancer cases are anticipated to collected retrospectively. The clinicopathological characteristics, treatment and survival information are retrospectively collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible cases were collected from a Chinese national database (Chinese Society of Clinical Oncology Breast Cancer database) and other involved centers.
Key inclusion criteria (2 listed)
- Biological sex is male;
- Microscopically diagnosed as primary breast cancer.
Key exclusion criteria (1 listed)
- Presence of skin-origin malignancy on the breast.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast cancerMale patients who were microscopically diagnosed as primary breast cancer. | Other | Chinese |
Primary outcome
Overall survival
Time frame: From the time of diagnosis to August 1, 2024 (anticipated).
The duration between the date of the first pathologic diagnosis and death from any cause or last follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Lin, MD, PhD principal investigator
1st affiliated hospital of Sun Yat-sen university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuxuan Gao, MD (+86 18142846375, gaoyx9@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From the time of diagnosis to August 1, 2024 (anticipated).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.