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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050109
• Other study ID #: HBCHBCC001
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: September 1, 2028

Study information

• Verified date: October 2023
• Source: Hubei Cancer Hospital
• Contact: Hongmei Zheng, Doctor
• Phone: 18971624606
• Email: zhenghongmeicj[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Endocrine Therapy

Intervention

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.

Diagnostic Test:
• Immunohistochemical detection of HR status
Enrolled patients must be HR-positive premenopausal breast cancer patients

Locations

Country	Name	City	State
China	Wu Xinhong	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Hongmei Zheng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	invasive disease-free survival	The main effect evaluation index was invasive disease-free survival (iDFS)	5 years
Secondary	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