OncoMatch/Clinical Trials/NCT06313983
A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer
Is NCT06313983 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Hemay022+AI and Lapatinib+Capecitabine for breast cancer.
Treatment: Hemay022+AI · Lapatinib+Capecitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER positive)
ER positive
Required: HER2 (ERBB2) overexpression (IHC 3+ and/or ISH positive)
HER2 over-expression (immunohistochemical IHC test 3+ and/or in situ hybridization ISH test positive)
Disease stage
Required: Stage IV
Metastatic disease required
Advanced/metastatic breast cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab, trastuzumab biosimilar)
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.
Cannot have received: HER2 tyrosine kinase inhibitor
Exception: medication course ≤2 weeks is excluded
Patients who have been treated with a small molecule HER2 tyrosine kinase inhibitor (HER2-TKI) (medication course ≤2 weeks is excluded)
Cannot have received: chemotherapy
Exception: ≤1 line for advanced breast cancer
Have received chemotherapy for advanced breast cancer > 1 lines
Cannot have received: radiation therapy
Have received radiotherapy within 4 weeks prior to study
Cannot have received: other clinical trial drugs
Have received other clinical trial drugs within 4 weeks before the study
Cannot have received: major surgery
Major surgery or injury less than 4 weeks before the study
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; Hemoglobin ≥90g/L (transfusion allowed); Platelet ≥80×10^9/L
Kidney function
serum creatinine ≤1.5 times ULN
Liver function
Liver function grade Child-Pugh A/B (≤9 points); ALT or AST ≤2.5 ULN in the absence of liver metastasis; ALT or AST ≤5x ULN with liver metastasis
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%
Adequate bone marrow, liver, kidney, and coagulation... Absolute value of neutrophils (ANC) ≥1.5×10^9/L Hemoglobin (HB) ≥90g/L (transfusion allowed) Platelet (PLT) ≥80×10^9/L Liver function grade Child-Pugh A/B (≤9 points) ALT or AST ≤2.5 ULN in the absence of liver metastasis; ALT or AST≤ 5x ULN with liver metastasis Renal function: serum creatinine ≤1.5 times ULN; Left ventricular ejection fraction (LVEF) <50％ as measured by echocardiogram or MUGA scan [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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