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

NCT ID: NCT06470633

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Breast Cancer; HR+/HER2- Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIFU+Adebrelimab+Chemotherapy

Induction phase: HIFU+Adebrelimab Neoadjuvant Therapy phase: Adebrelimab+ EC-T(Epirubicin + Cyclophosphamide → Docetaxel

Group Type: EXPERIMENTAL

Adebrelimab

Intervention Type: DRUG

Adebrelimab 1200mg iv q3w

High Intensity Focused Ultrasoun（HIFU）

Intervention Type: PROCEDURE

HIFU treatment at lesion site

Cyclophosphamide

Intervention Type: DRUG

600mg/m2 iv q3w

Epirubicin

Intervention Type: DRUG

90mg/m2 iv q3w

Docetaxel

Intervention Type: DRUG

75mg/m2 iv q3w

Interventions

Adebrelimab

Adebrelimab 1200mg iv q3w

Intervention Type: DRUG

High Intensity Focused Ultrasoun（HIFU）

HIFU treatment at lesion site

Intervention Type: PROCEDURE

Cyclophosphamide

600mg/m2 iv q3w

Intervention Type: DRUG

Epirubicin

90mg/m2 iv q3w

Intervention Type: DRUG

Docetaxel

75mg/m2 iv q3w

Intervention Type: DRUG

Other Intervention Names

PD-Li

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wenbin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wenbin Zhou, Professor

Role: CONTACT

Zhouwenbin@njmu.edu.cn

025-68308162

Other Identifiers

NJMU- BC03

Identifier Type: -

Identifier Source: org_study_id