To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+/HER2- Breast Cancer

Trial Title: To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+/HER2- Breast Cancer

NCT ID: NCT06470633

Condition: Breast Cancer
HR+/HER2- Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Cyclophosphamide
Docetaxel
Epirubicin

Conditions: Keywords:
HR+/HER2- early breast cancer
HIFU
Immunotherapy
Neoadjuvant therapy

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Adebrelimab
Description: Adebrelimab 1200mg iv q3w
Arm group label: HIFU+Adebrelimab+Chemotherapy

Other name: PD-Li

Intervention type: Procedure
Intervention name: High Intensity Focused Ultrasoun（HIFU）
Description: HIFU treatment at lesion site
Arm group label: HIFU+Adebrelimab+Chemotherapy

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: 600mg/m2 iv q3w
Arm group label: HIFU+Adebrelimab+Chemotherapy

Intervention type: Drug
Intervention name: Epirubicin
Description: 90mg/m2 iv q3w
Arm group label: HIFU+Adebrelimab+Chemotherapy

Intervention type: Drug
Intervention name: Docetaxel
Description: 75mg/m2 iv q3w
Arm group label: HIFU+Adebrelimab+Chemotherapy

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. 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; 2. 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; 3. Tumor size ≥ 3cm, and histological grade is 3 (poorly differentiated); 4. Regardless of lymph node status, but without distant metastasis; 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion; 6. ECOG PS score: 0 - 1; 7. New York Heart Association (NYHA) functional class I; 8. Electrocardiogram without myocardial ischemia, echocardiography LVEF > 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range; 9. Normal major organ function, Meet the following criteria: WBC ≥ 4.0 × 10 9/L,Neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet ≥ 100 × 10 9/L; hemoglobin ≥ 10 g/dL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN; 9.The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up. Exclusion Criteria: 1. 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; 2. 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.; 3. Known allergy to the active ingredients or other components of the study drug or surgical contraindications; 4. 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; 5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment; 6. Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator; 7. Patients who are participating in other clinical trials within one month; 8. Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension; 9. Any other conditions that in the opinion of the investigator would make the patient inappropriate for participation in this study.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: August 1, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Collaborator:
Agency: Jiangsu Hengrui Pharmaceuticals Co.,Ltd
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06470633