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

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

Trial Details

NCT ID
NCT06313983
Phase
PHASE3
Sponsor
Tianjin Hemay Pharmaceutical Co., Ltd
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Hemay022+AI
  • Lapatinib+Capecitabine
Locations (sample)
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • Age ≥18 years old；
  • Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;
  • Breast cancer subjects diagnosed by pathology（histology or cytology）;
  • ER positive and HER2 over-expression (immunohistochemical IHC test 3+ and/or in situ hybridization ISH test positive)；Previous test results are acc…

For full eligibility, visit ClinicalTrials.gov.

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