Combining stereotactic radiotherapy with immunotherapy and chemotherapy for treating triple-negative breast cancer

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

This study is testing if combining a new treatment with radiation and chemotherapy can help women with triple-negative breast cancer do better than just chemotherapy alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shengjing Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, adebrelimab
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06165900 on ClinicalTrials.gov

What this trial studies

This clinical trial is an open-label, multicenter, randomized study involving 136 patients with stage II-III triple-negative breast cancer. Participants will be assigned to either an experimental group receiving adebrelimab combined with stereotactic radiotherapy followed by chemotherapy, or a control group receiving adebrelimab with chemotherapy alone. The aim is to evaluate the effectiveness of this combination treatment in improving patient outcomes compared to standard chemotherapy. The study focuses on treatment-naïve female patients aged 18 to 75 with confirmed triple-negative breast cancer.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve female patients aged 18 to 75 with stage II-III triple-negative invasive breast cancer.

Not a fit: Patients with metastatic breast cancer or bilateral breast cancer will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective neoadjuvant treatment option for patients with triple-negative breast cancer.

How similar studies have performed: While there have been studies exploring combinations of immunotherapy and chemotherapy, this specific approach with stereotactic radiotherapy is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Shenyang, Liaoning

• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Caigang Liu, Dr.

Conditions Stereotactic Radiotherapy; Immunotherapy; Breast Cancer