The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
Recruiting · NCT06050109 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Immunohistochemical detection of HR statusOFS continues to use group after 5 years use
What this trial is 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.
Who can take part
Age range
18 Years to 60 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Wu Xinhong - Wuhan, Hubei, China