Early Breast CancerPRIORITYNCT07309887
This Clinical Trial is a Retrospective, Multicenter Cohort Study Evaluating the Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer.
An observational study of Early Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Breast Cancer
- How many people
- 100,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2025to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Key inclusion criteria: Adults (≥18 years) with stage I-III HR+/HER2- invasive breast cancer who underwent curative surgery Key exclusion criteria: HR- or HER2+ tumors, de novo stage IV, or lack of curative-intent surgery
Who may be able to join
- Patients (female or male) with a histologically confirmed first diagnosis of invasive breast cancer, identified by International Classification of Diseases, 10th Revision (ICD-10) code C50.x, between January 1, 2010, and December 31, 2023.* The date of diagnosis will be based on the initial pathology report or the date reported to the Korea Central Cancer Registry (KCCR).
- Age 18 years or older at the time of initial diagnosis.
- Anatomical stage I, II, or III disease at initial diagnosis, staged according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, using the edition contemporary to the time of diagnosis.
- Confirmed HR-positive disease, defined as estrogen receptor (ER) and/or progesterone receptor (PR) expression in ≥1% of invasive tumor cells on immunohistochemistry (IHC), or an Allred proportion score of 2 or higher.
- Confirmed HER2-negative disease, defined as an IHC score of 0 or 1+, or an IHC score of 2+ with a negative in situ hybridization (ISH) result (e.g., fluorescence in situ hybridization or silver in situ hybridization). Patients recorded as HER2-negative without a specific score available will also be included.
- Documented history of having received definitive (curative-intent) surgery for the primary breast cancer (e.g., breast-conserving surgery or mastectomy).
Who cannot join
- Patients (female or male) with a histologically confirmed first diagnosis of invasive breast cancer, identified by International Classification of Diseases, 10th Revision (ICD-10) code C50.x, between January 1, 2010, and December 31, 2023.* The date of diagnosis will be based on the initial pathology report or the date reported to the Korea Central Cancer Registry (KCCR).
- Age 18 years or older at the time of initial diagnosis.
- Anatomical stage I, II, or III disease at initial diagnosis, staged according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, using the edition contemporary to the time of diagnosis.
- Confirmed HR-positive disease, defined as estrogen receptor (ER) and/or progesterone receptor (PR) expression in ≥1% of invasive tumor cells on immunohistochemistry (IHC), or an Allred proportion score of 2 or higher.
- Confirmed HER2-negative disease, defined as an IHC score of 0 or 1+, or an IHC score of 2+ with a negative in situ hybridization (ISH) result (e.g., fluorescence in situ hybridization or silver in situ hybridization). Patients recorded as HER2-negative without a specific score available will also be included.
- Documented history of having received definitive (curative-intent) surgery for the primary breast cancer (e.g., breast-conserving surgery or mastectomy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul, 06351
SeonA Jang, CRC, 82-2-3410-1254, seona.jang@samsung.com
About this study
Official title: Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer: a Multi-center Retrospective Cohort Study in Korea
- Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy.
- Secondary objectives: Include assessment of relapse-free survival (RFS), distant disease-free survival (DDFS), distant relapse-free survival (DRFS), overall survival (OS), site of distant recurrence, and time-to-next treatment (TTNT), as well as evaluating the association between clinicopathologic/treatment variables and clinical outcomes.
- Key inclusion criteria: Adults (≥18 years) with stage I-III HR+/HER2- invasive breast cancer who underwent curative surgery
- Key exclusion criteria: HR- or HER2+ tumors, de novo stage IV, or lack of curative-intent surgery
- Conditions
- Early Breast Cancer
- Keywords
- Early breast cancer retrospective cohort study
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS (Event Free Survival)
The time from the index date (date of initiation of first systemic therapy or date of curative surgery, whichever occurs first) to the date of the first occurrence of any of the following events: disease progression that precludes the ability to perform definitive surgery (for patients receiving neoadjuvant therapy), invasive local or distant recurrence, the occurrence of a second primary invasive cancer, or death from any cause.
Measured: Its temporal window, which spans from 2010 to 2023
Secondary outcomes (6)
RFS
Time from index date to any recurrence (local/regional/distant) or death from any cause
Measured: Its temporal window, which spans from 2010 to 2023
DDFS
Time from index date to distant recurrence, second non-breast primary cancer, or death from any cause
Measured: Its temporal window, which spans from 2010 to 2023.
DRFS
Time from index date to distant recurrence or death from any cause
Measured: Its temporal window, which spans from 2010 to 2023
OS
Time from index date to death from any cause
Measured: Its temporal window, which spans from 2010 to 2023
Site of initial distant recurrence
The anatomical location(s) of the first documented distant metastatic lesion(s)
Measured: Its temporal window, which spans from 2010 to 2023
TTNT
Time from the initiation of first-line systemic therapy for advanced/metastatic disease to the initiation of a subsequent line of therapy or death from any cause
Measured: Its temporal window, which spans from 2010 to 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start17 Dec 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Breast CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Yeon Hee Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309887
- Sponsor's protocol ID
- 2025-08-005
- Acronym
- PRIORITY
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be decided later.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer: a Multi-center Retrospective Cohort Study in Korea
- ClinicalTrials.gov ID
- NCT07309887
- Acronym / sponsor ID
- PRIORITY / 2025-08-005
- Conditions
- Early Breast Cancer
- Keywords
- Early breast cancer retrospective cohort study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 17 Dec 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Dec 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.
- Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy.
- Secondary objectives: Include assessment of relapse-free survival (RFS), distant disease-free survival (DDFS), distant relapse-free survival (DRFS), overall survival (OS), site of distant recurrence, and time-to-next treatment (TTNT), as well as evaluating the association between clinicopathologic/treatment variables and clinical outcomes.
- Key inclusion criteria: Adults (≥18 years) with stage I-III HR+/HER2- invasive breast cancer who underwent curative surgery
- Key exclusion criteria: HR- or HER2+ tumors, de novo stage IV, or lack of curative-intent surgery
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Key inclusion criteria: Adults (≥18 years) with stage I-III HR+/HER2- invasive breast cancer who underwent curative surgery Key exclusion criteria: HR- or HER2+ tumors, de novo stage IV, or lack of curative-intent surgery
Key inclusion criteria (6 listed)
- Patients (female or male) with a histologically confirmed first diagnosis of invasive breast cancer, identified by International Classification of Diseases, 10th Revision (ICD-10) code C50.x, between January 1, 2010, and December 31, 2023.* The date of diagnosis will be based on the initial pathology report or the date reported to the Korea Central Cancer Registry (KCCR).
- Age 18 years or older at the time of initial diagnosis.
- Anatomical stage I, II, or III disease at initial diagnosis, staged according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, using the edition contemporary to the time of diagnosis.
- Confirmed HR-positive disease, defined as estrogen receptor (ER) and/or progesterone receptor (PR) expression in ≥1% of invasive tumor cells on immunohistochemistry (IHC), or an Allred proportion score of 2 or higher.
- Confirmed HER2-negative disease, defined as an IHC score of 0 or 1+, or an IHC score of 2+ with a negative in situ hybridization (ISH) result (e.g., fluorescence in situ hybridization or silver in situ hybridization). Patients recorded as HER2-negative without a specific score available will also be included.
Key exclusion criteria (6 listed)
- Patients (female or male) with a histologically confirmed first diagnosis of invasive breast cancer, identified by International Classification of Diseases, 10th Revision (ICD-10) code C50.x, between January 1, 2010, and December 31, 2023.* The date of diagnosis will be based on the initial pathology report or the date reported to the Korea Central Cancer Registry (KCCR).
- Age 18 years or older at the time of initial diagnosis.
- Anatomical stage I, II, or III disease at initial diagnosis, staged according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, using the edition contemporary to the time of diagnosis.
- Confirmed HR-positive disease, defined as estrogen receptor (ER) and/or progesterone receptor (PR) expression in ≥1% of invasive tumor cells on immunohistochemistry (IHC), or an Allred proportion score of 2 or higher.
- Confirmed HER2-negative disease, defined as an IHC score of 0 or 1+, or an IHC score of 2+ with a negative in situ hybridization (ISH) result (e.g., fluorescence in situ hybridization or silver in situ hybridization). Patients recorded as HER2-negative without a specific score available will also be included.
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
EFS (Event Free Survival)
Time frame: Its temporal window, which spans from 2010 to 2023
The time from the index date (date of initiation of first systemic therapy or date of curative surgery, whichever occurs first) to the date of the first occurrence of any of the following events: disease progression that precludes the ability to perform definitive surgery (for patients receiving neoadjuvant therapy), invasive local or distant recurrence, the occurrence of a second primary invasive cancer, or death from any cause.
6 secondary outcomes
RFS
Time frame: Its temporal window, which spans from 2010 to 2023
DDFS
Time frame: Its temporal window, which spans from 2010 to 2023.
DRFS
Time frame: Its temporal window, which spans from 2010 to 2023
OS
Time frame: Its temporal window, which spans from 2010 to 2023
Site of initial distant recurrence
Time frame: Its temporal window, which spans from 2010 to 2023
TTNT
Time frame: Its temporal window, which spans from 2010 to 2023
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 Dec 2025.
- Individual participant dataSharing planned: Undecided. It will be decided later.
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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.
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 Early Breast Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 6 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: opening soon, as of the sponsor's last update on 30 Dec 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 South Korea. 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?
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?
Contact Yeon Hee PARK, Ph.D (82-2-3410-1780, yeonh.park@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFS (Event Free Survival) (time frame: Its temporal window, which spans from 2010 to 2023). 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 Dec 2025.