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

Hongmei Zheng, PhD

Status: Enrolling

Conditions: Breast Cancer Female; Endocrine Therapy

Treatments: Diagnostic Test: Immunohistochemical detection of HR status; Drug: OFS continues to use group after 5 years use

Study type: Observational

Funder types: Other

Identifiers

NCT06050109

HBCHBCC001

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,200 participants in 2 patient groups

OFS continues to use after 5 years

Description:

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.

Treatment:

Drug: OFS continues to use group after 5 years use

Diagnostic Test: Immunohistochemical detection of HR status

OFS discontinues to use after 5 years

Description:

The control group did not need to continue to use OFS, either leuprolide or goserelin