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

GeneScience Pharmaceuticals (GenSci)

Status and phase: Active, not recruiting; Phase 3

Conditions: Breast Cancer Subjects

Treatments: Drug: T Leuprolide Injectable Emulsion; Drug: Leuprorelin Acetate Microspheres for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06449027

GenSci093-301

Details and patient eligibility

About

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

Full 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.

Enrollment: 211 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 2 patient groups

Leuprolide Injectable Emulsion

Experimental group

Description:

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

Treatment:

Drug: T Leuprolide Injectable Emulsion

Leuprorelin Acetate Microspheres for Injection

Active Comparator group

Description:

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

Treatment:

Drug: Leuprorelin Acetate Microspheres for Injection