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

NCT06470633 | Not Yet Recruiting Phase 2

• 1 other identifier: NJMU- BC03
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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

Keywords

HR+/HER2- early breast cancer; HIFU; Immunotherapy; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• tpCR

  total pathologic complete response rate（lymph node and breast）

  6 months

Secondary Outcomes (1)

• bpCR

  6 months

Study Arms (1)

HIFU+Adebrelimab+Chemotherapy

EXPERIMENTAL

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

Drug: Adebrelimab; Procedure: High Intensity Focused Ultrasoun（HIFU）; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Docetaxel

Interventions

Adebrelimab DRUG

Adebrelimab 1200mg iv q3w

Also known as: PD-Li

HIFU+Adebrelimab+Chemotherapy

High Intensity Focused Ultrasoun（HIFU） PROCEDURE

HIFU treatment at lesion site

HIFU+Adebrelimab+Chemotherapy

Cyclophosphamide DRUG

600mg/m2 iv q3w

HIFU+Adebrelimab+Chemotherapy

Epirubicin DRUG

90mg/m2 iv q3w

HIFU+Adebrelimab+Chemotherapy

Docetaxel DRUG

75mg/m2 iv q3w

HIFU+Adebrelimab+Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu Hengrui Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Epirubicin; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Central Study Contacts

Wenbin Zhou, Professor

CONTACT

025-68308162; Zhouwenbin@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share