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Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX®

NCT05110170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2023-05-16

No results posted yet for this study

Summary

This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with breast cancer.

Conditions

Interventions

DRUG

LY01005

LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period.

DRUG

ZOLADEX® 3.6 mg

ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, tamoxifen (10 mg/tablet, 1 tablet/time) was orally administered twice per day during the whole study period.

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2022-04-05
Completion
2022-06-24

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05110170 on ClinicalTrials.gov