Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Subjects

Outcome Measures

Primary Outcomes (1)

Observe the proportion of subjects whose E2 levels remain at postmenopausal levels between 4 and 48 weeks after treatment, to assess the Efficacy of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subject.
48 weeks

Secondary Outcomes (3)

Observe the concentration of LH, FSH, E2 after treatment.
48 weeks
Pharmacokinetic Parameter(AUC)
48 weeks
Pharmacokinetic Parameter(Cmax)
48 weeks

Study Arms (2)

Leuprolide Injectable Emulsion

EXPERIMENTAL

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

Drug: T Leuprolide Injectable Emulsion

Leuprorelin Acetate Microspheres for Injection

ACTIVE COMPARATOR

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

Drug: Leuprorelin Acetate Microspheres for Injection

Interventions

T Leuprolide Injectable EmulsionDrug

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.

Also known as: Tamoxifen Citrate Tablets

Leuprolide Injectable Emulsion

Leuprorelin Acetate Microspheres for InjectionDrug

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.

Eligibility Criteria

Age18 Years - 55 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Premenopausal female subjects aged 18 to 55 years old.
Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer.

Sponsors & Collaborators

Changchun GeneScience Pharmaceutical Co., Ltd.
Industrylead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

MeSH Terms

Interventions

TamoxifenInjections

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

Jian Zhang, Doctor
Fudan University
PRINCIPAL INVESTIGATOR
Zhimin Shao, Doctor
Fudan University
PRINCIPAL INVESTIGATOR

Enrollment

211 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 7, 2024

Study Start

August 21, 2024

Actual (reported)

Primary Completion

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Leuprolide Injectable Emulsion

Leuprorelin Acetate Microspheres for Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Leuprolide Injectable Emulsion

Leuprorelin Acetate Microspheres for Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations