A Multicenter RWS Study Comparing the Benefits of Continued Use of OFS After 5 Years

• Sponsor: Hongmei Zheng (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06050109
• Collaborator: (none)
• Enrollment: 1,426
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 147.1
• Patients Per Site Per Month: 9.7

Study Details

Study Description

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.

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, 2025. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.

Condition or Disease	Intervention/Treatment	Phase
To Observe and Evaluate the Clinical Efficacy and Safety of Continuous Use of OFS for Premenopausal Patients With Early Breast Cancer After 5 Years	Drug: OFS continues to use group after 5 years; Diagnostic Test: Immunohistochemical detection of HR status	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1426 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label, Non-randomized Controlled RWS Study Comparing the Benefits of Continued Use of OFS After 5 Years
• Actual Study Start Date: Aug 30, 2023
• Anticipated Primary Completion Date: Sep 1, 2030
• Anticipated Study Completion Date: Dec 1, 2035

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: OFS continues to use group after 5 years; Patients included in the trial group continued to use goserelin or leuprolide after 5 years.; Diagnostic Test: Immunohistochemical detection of HR status; Enrolled patients must be HR-positive premenopausal breast cancer patients
Active Comparator: 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

Outcome Measures

Primary Outcome Measures

1. invasive disease-free survival [5-10years]

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

Secondary Outcome Measures

1. Overall survival [5-15 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 Outcome Measures

1. Life quality score [5-15 years]

   Life quality 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with 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 (or waive 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wu Xinhong	Wuhan	Hubei	China

Sponsors and Collaborators

• Hongmei Zheng

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongmei Zheng, chief physician, Hubei Cancer Hospital
• ClinicalTrials.gov Identifier: NCT06050109
• Other Study ID Numbers: HBCHBCC001
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• 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
• Keywords provided by Hongmei Zheng, chief physician, Hubei Cancer Hospital: continued use of OFS after 5 years; RWS study; Hormone receptor (HR) positive HER2 negative breast cancer
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 22, 2023