NCT05122377

RWE About QOL and Compliance of Patients With OFS in China

QoL and Treatment Compliance for Pre-menopausal Patients With HR+ Breast Cancer Using GnRHa as Ovarian Function Suppression(OFS) Treatment in the Chinese Population: a Real-world Observational Investigation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 562 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the patient's feedback from using GnRHa depot formulation in postoperative, premenopausal patients with hormone receptor-positive breast cancer.

Detailed description

This was a real world, observational study of adjuvant therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. This trial is designed to compare patients' QOL and treatment compliance measured by FACT-B and self-administered questionnaires during OFS treatment period. Total score of FACT-B and self-administered questionaries, and change from baseline will be calculated and summarized descriptively. Change from baseline will be compared between GnRHa 3-month and GnRHa 1-month using ANCOVA model with baseline value as a covariate.The number depends on the patients who received questionnaire during 18 months recruitment in planned 10 sites. This analytical plan assumes homogeneity across 10 sites so that strata is not considered.

Conditions

• Breast Cancer
• Quality of Life
• Hormone Receptor-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	3M GnRHa	This was a real world, observational study of adjuvant endocrine therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. Patients will receive treatment per GnRHa commercial label instruction: leuprorelin, goserelin, leuprorelin from local like: acetate microspheres sustained for injection(boennuokang), leuprorelin acetate microspheres for injection(beiyi).
DRUG	1M GnRHa	This was a real world, observational study of adjuvant endocrine therapy with GnRHa for OFS in postoperative, premenopausal women with endocrine responsive breast cancer. Patients will receive treatment per GnRHa commercial label instruction: leuprorelin, goserelin, leuprorelin from local like: acetate microspheres sustained for injection(boennuokang), leuprorelin acetate microspheres for injection(beiyi).

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2021-11-16
• Last updated: 2026-01-06

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study