NCT06313983

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

A Phase Ⅲ Randomized, Open Label, Parallel, Multicenter To Assess Efficacy and Safety Study of Hemay022 in Combination With AI In Postmenopausal HER2+/ER+ Advanced Breast Cancer Patients Treated With Trastuzumab-containing Regimens

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (estimated)
• Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Hemay022+AI	hemay022：orally once daily，A 21-day cycle
DRUG	Lapatinib+Capecitabine	Take the pills according to the instructions

Timeline

• Start date: 2022-01-08
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2024-03-15
• Last updated: 2025-04-22

Locations

1 site across 1 country: China