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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165900
• Other study ID #: MUKDEN 08
• Status: Recruiting
• Phase: Phase 2
• Start date: September 26, 2023
• Est. completion date: December 15, 2028

Study information

• Verified date: January 2024
• Source: Shengjing Hospital
• Contact: Caigang Liu, Dr.
• Phone: 18940254967
• Email: liucg[@]sj-hospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 15, 2028
• Est. primary completion date: December 15, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Immunotherapy

Intervention

Drug:
• adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)
Adebrelimab plus radiotherapy phase: radiotherapy was started on the day of the second cycle of adebrelimab administration every other day for 3 fractions; Adebrelimab plus chemotherapy phase: starting within 3-5 weeks after completion of radiotherapy, every 3 weeks for 6 cycles.
• adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)
adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tpCR	total pathologic complete response	6 months