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

A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing 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.

Study Overview

• Status: Recruiting
• Conditions: Endocrine Therapy; Breast Cancer Female
• Intervention / Treatment: Diagnostic test: Immunohistochemical detection of HR status; Drug: OFS continues to use group after 5 years use

• Study Type: Observational
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongmei Zheng, Doctor; Phone Number: +86 18971624606; Email: zhenghongmeicj@163.com
• Study Contact Backup: Name: Xinhong Wu, Doctor; Phone Number: +86 18602726300; Email: wuxinhong_9@sina.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Wu Xinhong
      • Contact: xinhong wu, Dr; Phone Number: +8618602726300; Email: wuxinhong_9@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women who are diagnosed as early breast cancer and have received 5 years treatment of OFS.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Immunohistochemical detection of HR status; Enrolled patients must be HR-positive premenopausal breast cancer patients; Drug: OFS continues to use group after 5 years use; 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
OFS discontinues to use after 5 years; The control group did not need to continue to use OFS, either leuprolide or goserelin	Diagnostic test: Immunohistochemical detection of HR status; Enrolled patients must be HR-positive premenopausal breast cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
invasive disease-free survival	The main effect evaluation index was invasive disease-free survival (iDFS)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	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.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life score	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.	5 years

Collaborators and Investigators

• Sponsor: Hongmei Zheng
• Investigators: Principal Investigator: Hongmei Zheng, Doctor, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 17, 2023
• First Submitted That Met QC Criteria: September 17, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: HER2 negative; early breast cancer; ovarian function suppression; Hormone receptor (HR) positive; prolonged therapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: HBCHBCC001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No