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ACTIVE NOT RECRUITING
NCT05077449
PHASE3

A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic breast cancer and have received prior endocrine therapy are eligible for study.

Official title: A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 in Combination With Fulvestrant Versus Placebo Combined With Fulvestrant in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2021-11-16

Completion Date

2029-11

Last Updated

2024-05-24

Healthy Volunteers

No

Interventions

DRUG

XZP-3287+Fulvestrant

XZP-3287 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease

DRUG

Placebo + Fulvestrant

Placebo 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease

Locations (1)

Chinese Academy of Medical Science

Beijing, Beijing Municipality, China