RECRUITINGOBSERVATIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form; - The researcher believes that it can benefit. Who Should NOT Join This Trial: - The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years - cancer that has spread to the brain 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

OFS continues to use group after 5 years use

Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.

DIAGNOSTIC_TEST

Immunohistochemical detection of HR status

Enrolled patients must be HR-positive premenopausal breast cancer patients

Locations (1)

Wu Xinhong

Wuhan, Hubei, China