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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Wu Xinhong
RECRUITING
Wuhan
Contact Information
Primary
Hongmei Zheng, Doctor
zhenghongmeicj@163.com
18971624606
Backup
Xinhong Wu, Doctor
wuxinhong_9@sina.com
18602726300
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 1200
Treatments
OFS continues to use after 5 years
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.
OFS discontinues to use after 5 years
The control group did not need to continue to use OFS, either leuprolide or goserelin
Related Therapeutic Areas
Sponsors
Leads: Hongmei Zheng, PhD

This content was sourced from clinicaltrials.gov

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