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

ConditionsBreast Cancer Female Endocrine Therapy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18-60

SponsorHongmei Zheng, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.
Immunohistochemical detection of HR status
Diagnostic test
Enrolled patients must be HR-positive premenopausal breast cancer patients

Treatment groups

1,200 Participants

are divided into 2 treatment groups

Group A: OFS continues to use after 5 years2 interventions

Group B: OFS discontinues to use after 5 years0 interventions

Trial outcomes

Primary outcomes

invasive disease-free survival

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

Time frame

5 years

Secondary outcomes

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.

Time frame

5 years

Other outcomes

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.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hongmei Zheng, PhD

Lead sponsor

Hubei Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov

Apply now