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

Официальное название

To Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy Neoadjuvant Therapy in Early or Local Advanced Breast Cancer After Induction Treatment of High-intensity Focused Ultrasound and Adebrelimab

Обзор

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.

Вмешательства

• Препарат Adebrelimab
  Adebrelimab 1200mg iv q3w
• Процедура High Intensity Focused Ultrasoun（HIFU）
  HIFU treatment at lesion site
• Препарат Cyclophosphamide
  600mg/m2 iv q3w
• Препарат Epirubicin
  90mg/m2 iv q3w
• Препарат Docetaxel
  75mg/m2 iv q3w

Первичные конечные точки

• tpCR [Срок оценки: 6 months]

Вторичные конечные точки (1)

• bpCR [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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;
• According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;
• ECOG PS score: 0 - 1;
• New York Heart Association (NYHA) functional class I;
• Electrocardiogram without myocardial ischemia, echocardiography LVEF > 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;
• 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.

Критерии исключения

• 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;
• Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;
• Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;
• Patients who are participating in other clinical trials within one month;
• 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;
• Any other conditions that in the opinion of the investigator would make the patient inappropriate for participation in this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06470633 · NJMU- BC03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗