A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old； 2. Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form; 3. Breast cancer subjects diagnosed by pathology（histology or cytology）; 4. ER positive and HER2 over-expression (immunohistochemical IHC test 3+ and/or in situ hybridization ISH test positive)；Previous test results are acceptable. 5. Advanced/metastatic breast cancer that has previously received treatment failure with trastuzumab (or trastuzumab biosimilar) regimen;Or (new) adjuvant therapy during treatment with trastuzumab (or trastuzumab biosimilar) or within 12 months after the end of treatment, disease recurrence or progression；Patients with first-line systemic treatment for relapse (previously received trastuzumab or trastuzumab biosimilars)；Or patients who are not suitable for trastuzumab treatment；Patients who have failed previous anti-HER2-ADC drug therapy can also be included. 6. At least one lesion (measura