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A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer

NCT06313983 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2025-04-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI.

The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc.

Conditions

Interventions

DRUG

Hemay022+AI

hemay022：orally once daily，A 21-day cycle

DRUG

Lapatinib+Capecitabine

Take the pills according to the instructions

Sponsors & Collaborators

  • Tianjin Hemay Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-08
Primary Completion
2025-12-31
Completion
2026-06-30

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 NCT06313983 on ClinicalTrials.gov