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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

211

Participants

Timeline

Start Date

August 21, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

March 31, 2026

Conditions
Breast Cancer Subjects
Interventions
DRUG

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.

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.

Trial Locations (1)

200032

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
lead

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

NCT06449027 - Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects. | Biotech Hunter | Biotech Hunter