Clinical trial NCT06165900: Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stereotactic Radiotherapy
Immunotherapy
Breast Cancer
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: tpCR
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
References: