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ACTIVE NOT RECRUITING
NCT05257395
PHASE3

A Study of XZP-3287 in Combination With Letrozole/Anastrozole in Patients With Advanced Breast Cancer

Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase III clinical trial designed to evaluate the efficacy and safety of XZP-3287 in combination with Letrozole/Anastrozole versus placebo in combination with Letrozole/Anastrozole in patients with HR-positive and HER2-negative recurrent/metastatic breast cancer who have not received systemic anticancer therapy.

Official title: A Phase III Study to Evaluate the Efficacy and Safety of XZP-3287 Combined With Letrozole/Anastrozole Versus Placebo Combined With Letrozole/Anastrozole 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

397

Start Date

2022-03-14

Completion Date

2030-09-05

Last Updated

2025-07-17

Healthy Volunteers

No

Interventions

DRUG

XZP-3287+ Letrozole/Anastrozole

XZP-3287 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle

DRUG

Placebo + Letrozole/Anastrozole

Placebo 360 mg orally after meals Twice daily of every 28-day cycle; Letrozole tablets 2.5mg orally once daily of every 28-day cycle or Anastrozole tablets 1mg orally once daily of every 28-day cycle

Locations (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China