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RecruitingNCT06165900Updated Jan 3, 2024

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

A Phase 2 interventional study of adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) and adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin) in Stereotactic Radiotherapy, Immunotherapy and Breast Cancer, sponsored by Shengjing Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Shengjing Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years later.
Phase
Phase 2
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Stereotactic Radiotherapy
  • Immunotherapy
  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 136 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shengjing Hospital is the lead sponsor of 124 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    adebrelimab plus stereotactic radiotherapy and chemotherapy

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

  • Active comparator
    adebrelimab plus nab-paclitaxel + carboplatin

    Drug: adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

Interventions

  • Drugadebrelimab 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.

  • Drugadebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

    adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

06

What researchers measure

Primary outcomes

  1. tpCR

    total pathologic complete response

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Shengjing Hospital of China Medical University
    Shenyang, Liaoning 110022, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06165900
Lead sponsor
Shengjing Hospital
Responsible party
Caigang Liu (Clinical Professor, Shengjing Hospital) — Principal investigator
First posted
Dec 12, 2023
Start date
Sep 26, 2023
Primary completion
Dec 15, 2025 (estimated)
Completion
Dec 15, 2028 (estimated)
Last update
Jan 3, 2024

Study contacts

Caigang Liu, Dr.
Contact
liucg@sj-hospital.org
18940254967
Nan Niu, Dr.
Contact
niunannancy@163.com
18940256668

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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