Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

NCT ID: NCT06449027

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-21
• Study Completion Date: 2026-03-31

Brief Summary

The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.

Detailed Description

This is a multicenter, randomized, open-Label , non-inferiority phase III study . All premenopausal women breast cancer subjects were randomly allocated to either the study group or control group in a 1:1 ratio. Furthermore, all subjects received tamoxifen citrate treatment throughout the entire duration of the study. The efficacy of maintaining serum E2 levels ≤30 pg/mL at 4-48 weeks post-treatment will be assessed in both groups.

Conditions

Breast Cancer Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leuprolide Injectable Emulsion

100 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks.

Group Type: EXPERIMENTAL

T Leuprolide Injectable Emulsion

Intervention Type: DRUG

Arm 1 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.

Leuprorelin Acetate Microspheres for Injection

100 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks.

Group Type: ACTIVE_COMPARATOR

Leuprorelin Acetate Microspheres for Injection

Intervention Type: DRUG

Arm 2 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.

Interventions

T Leuprolide Injectable Emulsion

Arm 1 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.

Intervention Type: DRUG

Leuprorelin Acetate Microspheres for Injection

Arm 2 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.

Intervention Type: DRUG

Other Intervention Names

Tamoxifen Citrate Tablets; Tamoxifen Citrate Tablets

Eligibility Criteria

Inclusion Criteria

• Premenopausal female subjects aged 18 to 55 years old.
• Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer.
• Subjects have any breast cancer surgery before informing, and no clinical residual local regional lesions were found after the surgery.
• Life expectancy is not less than 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate function of major organs.

Exclusion Criteria

• History of evidence of distant metastatic lesions;
• Subjects have the history of new adjuvant or adjuvant endocrine treatment for breast cancer ( Excluding subjects receiving tamoxifen citrate tablets treatment for less than 12 weeks before informing).
• Active hepatitis B, hepatitis C or HIV in screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Zhimin Shao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

GenSci093-301

Identifier Type: -

Identifier Source: org_study_id