Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07309887

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.

* 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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Early Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. RFS

    Time frame: Its temporal window, which spans from 2010 to 2023

    Time from index date to any recurrence (local/regional/distant) or death from any cause

  2. DDFS

    Time frame: Its temporal window, which spans from 2010 to 2023.

    Time from index date to distant recurrence, second non-breast primary cancer, or death from any cause

  3. DRFS

    Time frame: Its temporal window, which spans from 2010 to 2023

    Time from index date to distant recurrence or death from any cause

  4. OS

    Time frame: Its temporal window, which spans from 2010 to 2023

    Time from index date to death from any cause

  5. Site of initial distant recurrence

    Time frame: Its temporal window, which spans from 2010 to 2023

    The anatomical location(s) of the first documented distant metastatic lesion(s)

  6. TTNT

    Time frame: Its temporal window, which spans from 2010 to 2023

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Yeon Hee PARK, Ph.D

CONTACT

[email protected]

82-2-3410-1780

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Novartis

Registry information

Official study 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

Acronym: PRIORITY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.