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Search / Trial NCT06050109

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

Launched by HONGMEI ZHENG, PHD · Sep 17, 2023

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Ovarian Function Suppression Hormone Receptor (Hr) Positive Her2 Negative Early Breast Cancer Prolonged Therapy

ClinConnect Summary

This clinical trial is looking into the benefits of continuing a treatment called Ovarian Function Suppression (OFS) for women who have had early-stage breast cancer and have already been on OFS for five years. The main goal is to see if continuing this treatment for longer helps improve health outcomes and is safe for patients. The study will compare two groups of women: those who keep using OFS after five years and those who stop.

To join this study, participants need to be women aged 18 to 60 who have been diagnosed with early-stage breast cancer that is hormone receptor positive and HER2 negative. They must have already completed five years of OFS treatment and be in good overall health. Women who are interested will need to give their consent to participate. Throughout the trial, participants can expect regular check-ins and monitoring to assess their health and any effects of the treatment. It’s important to know that this study aims to gather real-world data, meaning it uses information from everyday medical practices to make its findings.

Gender

FEMALE

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

About Hongmei Zheng, Phd

Dr. Hongmei Zheng, PhD, is a distinguished clinical trial sponsor with extensive expertise in pharmaceutical research and development. With a robust background in biostatistics and clinical methodologies, Dr. Zheng leads initiatives aimed at advancing innovative therapies through rigorous trial design and execution. Her commitment to enhancing patient outcomes is reflected in her collaborative approach, engaging multidisciplinary teams to ensure compliance with regulatory standards and ethical guidelines. Dr. Zheng's contributions to the field are marked by a dedication to scientific integrity and a passion for translating research findings into tangible health solutions.

Locations

Wuhan, Hubei, China

Patients applied

0 patients applied

Trial Officials

Hongmei Zheng, Doctor

Principal Investigator

Study Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported