The Benefits of Continued Use of Ovarian Function Suppression After 5 Years

Study Overview
=================
Brief Summary
-----------------
To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS. This study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.

Official Title
-----------------
A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years

Conditions
-----------------
Breast Cancer Female, Endocrine Therapy

Intervention / Treatment
-----------------
* Drug: OFS continues to use group after 5 years use
* Diagnostic Test: Immunohistochemical detection of HR status


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with early primary breast cancer Female aged 18-60 years (including 18 year and 60 year) Hormone receptor (HR) positive HER2 negative Receive 5 years of OFS treatment ECOG score 0-1 Voluntarily join this study and sign the informed consent form; The researcher believes that it can benefit. Exclusion Criteria: The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision Invasive metastases with known obvious symptoms Invasive metastases with known obvious symptoms Doctors think it is not suitable for inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OFS continues to use after 5 years<br>HR-positive premenopausal female patients whose doctors believe that they can benefit from continued use of OFS after 5 years should be included in the trial group. | Drug: OFS continues to use group after 5 years use<br>* Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.<br>* Other names: OFS discontinues to use group after 5 years use;Diagnostic Test: Immunohistochemical detection of HR status<br>* Enrolled patients must be HR-positive premenopausal breast cancer patients<br>|
| OFS discontinues to use after 5 years<br>The control group did not need to continue to use OFS, either leuprolide or goserelin | Diagnostic Test: Immunohistochemical detection of HR status<br>* Enrolled patients must be HR-positive premenopausal breast cancer patients<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| invasive disease-free survival | The main effect evaluation index was invasive disease-free survival (iDFS) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival for years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian function suppression, Hormone receptor (HR) positive, HER2 negative, early breast cancer, prolonged therapy