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Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC

A Multicenter, Randomized Trial of Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) Versus Adebrelimab Combined With TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of Triple-negative Breast Cancer

NCT06165900•Shengjing Hospital

View on ClinicalTrials.gov

Summary

This study was an open-label, multicenter, randomized study. It is planned to include 136 patients with stage II-III triple negative breast cancer. Eligible subjects will be randomized to receive either the experimental arm: adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) or the control arm: adebrelimab plus nab-paclitaxel + carboplatin.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
•Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC \< 1%, PR negative: IHC \< 1%, HER2 negative: IHC 0/1 + or IHC2 + but ISH negative;
•Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
•ECOG score 0-1;
•Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
•Appropriate level of organ function
•Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.

Exclusion Criteria

•Patients with metastatic breast cancer or bilateral breast cancer;
•Patients with inflammatory breast cancer or occult breast cancer;
•Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization;
•Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
•Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.
•Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;
•Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test)
•Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.

Locations (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Key Dates

Start Date

September 26, 2023

Primary Completion Date

December 15, 2025

Completion Date

December 15, 2028

Last Updated

January 3, 2024

Enrollment

136

ESTIMATED participants

Conditions

Stereotactic RadiotherapyImmunotherapyBreast Cancer

Interventions

adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

DRUG

adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

DRUG

Contacts

Caigang Liu, Dr.

CONTACT

18940254967 liucg@sj-hospital.org

Nan Niu, Dr.

CONTACT

18940256668 niunannancy@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC

Inclusion Criteria

Exclusion Criteria

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