MedTrace Logo

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

NCT05257395 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 397

Last updated 2025-07-17

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Xuanzhu Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qingyuan Zhang · The Second Affiliated Hospital of Harbin Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2025-12-05
Completion
2030-09-05

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 NCT05257395 on ClinicalTrials.gov