A Phase II Exploratory Study of Iparomlimab and Tuvonralimab Combined With Chemotherapy in Neoadjuvant Treatment of HR+/HER2- Breast Cancer Patients

No open prediction endpoints

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Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: * The patient must meet all of the following criteria to be included in the study: 1. Age ≥ 18 years and ≤ 75 years, regardless of gender; 2. The primary lesion tissue pathology is confirmed as HR+/HER2- breast cancer, following the 2018 ASCO/CAP breast cancer HER2 testing guidelines and the 2010 ASCO/CAP breast cancer ER/PR testing guidelines for interpretation. HER2-negative is defined as confirmed by the pathology laboratory with an immunohistochemistry (IHC) score of HER2 0/1+ or 2+ and negative in in situ hybridization (ISH), and estrogen receptor positive (ER+) breast cancer with or without progesterone receptor (PgR) expression; 3. Tumor histological grade 3, or histological grade 2 with the percentage of ER expression level between 1-10%; 4. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM classification, the clinical stage should be T1c-T2cN1-2 or T3-4cN0-2, M0 stage; 5. At least one measurable lesion (in accordance wit…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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