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NCT Number: NCT06050109

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

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Endocrine Therapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OFS continues to use group after 5 years use

Drug

Patients included in the group continued or discontinued to use goserelin or leuprolide after 5 years use.

Other names: OFS discontinues to use group after 5 years use

Immunohistochemical detection of HR status

Diagnostic Test

Enrolled patients must be HR-positive premenopausal breast cancer patients

Primary outcomes

  1. invasive disease-free survival

    Time frame: 5 years

    The main effect evaluation index was invasive disease-free survival (iDFS)

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    Overall survival for years, which means the rate of patients alive in the whole patients at the same group will be calculated with kaplan meier survival curves.

Other outcomes

  1. Quality of life score

    Time frame: 5 years

    Quality of life score was evaluated by European Organization of Research and treatment of Cancer-Questionnaire of Life Quality-C30 Version 3 (EORTC-QLQ-C30 V3), which conduct a series of questions about the patients' physical condition, activity of daily life, adverse reaction and mood condition. The range in the questionnaire for the score is from 1 to 4, in which 1 stands for having no discomfort and 4 stands for having great discomfort.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongmei Zheng, Doctor

CONTACT

[email protected]

18971624606 ext. +86

Xinhong Wu, Doctor

CONTACT

[email protected]

18602726300 ext. +86

Sponsors and collaborators

Lead sponsor

Hongmei Zheng, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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