To explore the efficacy and safety of adebrelimab combined with chemotherapy (epirubicin + cyclophosphamide →docetaxel) neoadjuvant therapy early HR+/HER2- breast cancer with high risk factors after the induction treatment of HIFU and adebrelimab.
Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;
Histopathologically confirmed breast cancer patients who with hormone receptor- positive, which defined as estrogen receptor (ER) ≥ 1%, and/ or progesterone receptor (PR) ≥ 1%, and HER-2 (0 or +), or ++,but FISH is no amplification;
Tumor size ≥ 3cm, and histological grade is 3 (poorly differentiated);
Regardless of lymph node status, but without distant metastasis;
Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;
Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;
Known allergy to the active ingredients or other components of the study drug or surgical contraindications;
In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;
Single group
Adebrelimab
DrugAdebrelimab 1200mg iv q3w
High Intensity Focused Ultrasoun（HIFU）
Procedure/SurgeryHIFU treatment at lesion site
Cyclophosphamide
Drug600mg/m2 iv q3w
Epirubicin
Drug90mg/m2 iv q3w
Docetaxel
Drug75mg/m2 iv q3w
tpCR
total pathologic complete response rate（lymph node and breast）
bpCR
breast pathologic complete response rate
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The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
