Breast CancerBC-MRS-01NCT07052734
Miti-gene Recurrence Score in HR+/HER2- Chinese Breast Cancer Patients
An observational study of Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- How many people
- 2,843 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 18 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HR-positive, HER2-negative breast cancer
Who may be able to join
- Diagnosed age: 18-75 years.
- Early-stage invasive breast cancer, pN0-1.
- Molecular subtype: HR-positive (ER and/or PR positive), HER2-negative.
- At least five years of follow-up records (including cases with disease progression within five years and documented records).
- Sufficient FFPE samples for sectioning or frozen samples for RNA extraction and subsequent testing.
Who cannot join
- FFPE samples with tumor content <20%, and inability to enrich tumor regions through cutting.
- Insufficient extracted nucleic acid quantity or severe degradation preventing further experiments.
- Failure in RT-PCR amplification of housekeeping genes.
- Multiple primary breast cancers or a history of ipsilateral or contralateral breast cancer.
- Disease progression unrelated to breast cancer.
- Lack of prior signed consent for retrospective scientific research or exemption from informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Retrospective Analysis of the Miti-gene Recurrence Score in Early-Stage Invasive HR-Positive, HER2-Negative Breast Cancer in China
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-Free Survival (DFS) is defined as the duration from the completion of curative surgery until the first occurrence of any of the following events: local or distant relapse of the breast cancer, development of a new primary cancer, or death from any cause.
Measured: 10 years
Secondary outcomes (2)
Overall survival
Overall survival is defined as the duration from the completion of curative surgery until death from any cause.
Measured: 10 years
Distant relapse-free survival
Distant relapse-free survival is defined as the duration from the completion of curative surgery until distant relapse of the breast cancer.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2025
- Study start1 Dec 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
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 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
- 2,843 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang shusen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052734
- Sponsor's protocol ID
- BC-MRS-01
- Acronym
- BC-MRS-01
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2025
- Last updated
- 6 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Retrospective Analysis of the Miti-gene Recurrence Score in Early-Stage Invasive HR-Positive, HER2-Negative Breast Cancer in China
- ClinicalTrials.gov ID
- NCT07052734
- Acronym / sponsor ID
- BC-MRS-01 / BC-MRS-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,843 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 6 Jul 2025 (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.
Update and validate the performance of the 21-gene score in prognostic stratification for early-stage HR-positive, HER2-negative breast cancer in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HR-positive, HER2-negative breast cancer
Key inclusion criteria (5 listed)
- Diagnosed age: 18-75 years.
- Early-stage invasive breast cancer, pN0-1.
- Molecular subtype: HR-positive (ER and/or PR positive), HER2-negative.
- At least five years of follow-up records (including cases with disease progression within five years and documented records).
- Sufficient FFPE samples for sectioning or frozen samples for RNA extraction and subsequent testing.
Key exclusion criteria (6 listed)
- FFPE samples with tumor content <20%, and inability to enrich tumor regions through cutting.
- Insufficient extracted nucleic acid quantity or severe degradation preventing further experiments.
- Failure in RT-PCR amplification of housekeeping genes.
- Multiple primary breast cancers or a history of ipsilateral or contralateral breast cancer.
- Disease progression unrelated to breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease-free survival
Time frame: 10 years
Disease-Free Survival (DFS) is defined as the duration from the completion of curative surgery until the first occurrence of any of the following events: local or distant relapse of the breast cancer, development of a new primary cancer, or death from any cause.
2 secondary outcomes
Overall survival
Time frame: 10 years
Distant relapse-free survival
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 6 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 10 years). 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 6 Jul 2025.