NCT06050109 The Benefits of Continued Use of Ovarian Function Suppression After 5 Years
| NCT ID | NCT06050109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hongmei Zheng, PhD |
| Condition | Breast Cancer Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,200 participants in total. It began in 2023-09-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Hongmei Zheng, Doctor
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT06050109 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06050109 currently recruiting?
Yes, NCT06050109 is actively recruiting participants. Contact the research team at zhenghongmeicj@163.com for enrollment information.
Where is the NCT06050109 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06050109 clinical trial?
NCT06050109 is sponsored by Hongmei Zheng, PhD. The principal investigator is Hongmei Zheng, Doctor at Study Principal Investigator. The trial plans to enroll 1,200 participants.
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