Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
NCT ID: NCT06165900
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
136 participants
INTERVENTIONAL
2023-09-26
2028-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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adebrelimab plus stereotactic radiotherapy and chemotherapy
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 nab-paclitaxel + carboplatin
adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)
adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Shengjing Hospital
OTHER
Responsible Party
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Caigang Liu
Clinical Professor
Locations
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Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MUKDEN 08
Identifier Type: -
Identifier Source: org_study_id
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