NCT06050109

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
28mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Sep 2023Sep 2028

Study Start

First participant enrolled

September 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 17, 2025

Status Verified

October 1, 2024

Enrollment Period

5 years

First QC Date

September 17, 2023

Last Update Submit

March 14, 2025

Conditions

Breast Cancer FemaleEndocrine Therapy

Keywords

ovarian function suppressionHormone receptor (HR) positiveHER2 negativeearly breast cancerprolonged therapy

Outcome Measures

Primary Outcomes (1)

  • invasive disease-free survival

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

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Other Outcomes (1)

  • Quality of life score

    5 years

Study Arms (2)

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 useDiagnostic Test: Immunohistochemical detection of HR status

OFS discontinues to use after 5 years

The control group did not need to continue to use OFS, either leuprolide or goserelin

Interventions

OFS continues to use group after 5 years useDRUG

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

Also known as: OFS discontinues to use group after 5 years use
OFS continues to use after 5 years
Immunohistochemical detection of HR statusDIAGNOSTIC_TEST

Enrolled patients must be HR-positive premenopausal breast cancer patients

OFS continues to use after 5 years

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wu Xinhong

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hongmei Zheng, Doctor

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongmei Zheng, Doctor

CONTACT

18971624606zhenghongmeicj@163.com

Xinhong Wu, Doctor

CONTACT

18602726300wuxinhong_9@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice director

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 22, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 17, 2025

Record last verified: 2024-10

Locations

CN(1)