Breast CancerNCT07093775
Additional Prognostic Value of Tumor Grade Beyond the 21-gene Recurrence Score
An observational study of Breast Cancer and Tumor Grade, run by Gangnam Severance Hospital.
Trial summary
To evaluated the prognostic significance of tumor grade in patients with node-negative, hormone receptor-positive, and human epidermal growth factor receptor 2-negative breast cancers treated according to RS-guided strategies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Breast Cancer, Tumor Grade
- What is being tested?
- Tumor grade (I or II vs. III)
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HR-positive, HER2-negative breast cancer who were node-negative and underwent curative surgery followed by 21-gene Oncotype DX testing
Who may be able to join
- Patients with hormone receptor-positive, HER2-negative early-stage breast cancer
- Patients treated between January 2011 and December 2023
- Patients with available clinicopathologic data and 21-gene Oncotype DX assay results confirmed through electronic medical records
Who cannot join
- Patients with breast cancer under the age of 20
- Patients diagnosed with stage IV breast cancer
- Patients for whom clinicopathologic data cannot be retrieved from electronic medical records
About this study
Official title: Prognostic Implication of Tumor Grade in Patients With Node-negative Breast Cancer Aged ≤ 50 Years With 21-gene Recurrence Scores of 11-25
To evaluated the prognostic significance of tumor grade in patients with node-negative, hormone receptor-positive, and human epidermal growth factor receptor 2-negative breast cancers treated according to RS-guided strategies.
- Conditions
- Breast Cancer, Tumor Grade
- Being tested
- Tumor grade (I or II vs. III)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor grade (I or II vs. III)Other
We compared the prognosis according to the tumor grade stratified by 21-gene recurrence score
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free interval
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (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.
- 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Gwe Ahn, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093775
- Sponsor's protocol ID
- 3-2025-0107
- Status last verified
- Jun 2025
- First submitted
- 15 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Implication of Tumor Grade in Patients With Node-negative Breast Cancer Aged ≤ 50 Years With 21-gene Recurrence Scores of 11-25
- ClinicalTrials.gov ID
- NCT07093775
- Acronym / sponsor ID
- 3-2025-0107
- Conditions
- Breast Cancer, Tumor Grade
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 30 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.
To evaluated the prognostic significance of tumor grade in patients with node-negative, hormone receptor-positive, and human epidermal growth factor receptor 2-negative breast cancers treated according to RS-guided strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HR-positive, HER2-negative breast cancer who were node-negative and underwent curative surgery followed by 21-gene Oncotype DX testing
Key inclusion criteria (3 listed)
- Patients with hormone receptor-positive, HER2-negative early-stage breast cancer
- Patients treated between January 2011 and December 2023
- Patients with available clinicopathologic data and 21-gene Oncotype DX assay results confirmed through electronic medical records
Key exclusion criteria (3 listed)
- Patients with breast cancer under the age of 20
- Patients diagnosed with stage IV breast cancer
- Patients for whom clinicopathologic data cannot be retrieved from electronic medical records
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 |
|---|---|---|
| Tumor grade (I or II vs. III)We compared the prognosis according to the tumor grade stratified by 21-gene recurrence score | Other | – |
Primary outcome
Recurrence-free interval
Time frame: through study completion, an average of 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Tumor Grade, run by Gangnam Severance Hospital.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Recurrence-free interval (time frame: through study completion, an average of 5 year). 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 30 Jul 2025.