Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06313983
PHASE3

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

Sponsor: Tianjin Hemay Pharmaceutical Co., Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

339

Start Date

2022-01-08

Completion Date

2026-06

Last Updated

2025-04-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Hemay022+AI

hemay022:orally once daily,A 21-day cycle

DRUG

Lapatinib+Capecitabine

Take the pills according to the instructions

Locations (1)

Beijing Cancer Hospital

Beijing, China