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NCT Number: NCT06165900

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110022, China

Location status: Recruiting

Location contact

Nan Niu, Phd

CONTACT

[email protected]

+8618940256668

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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)

Drug

adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)

Primary outcomes

  1. tpCR

    Time frame: 6 months

    total pathologic complete response

Study contacts

Contact information is provided by the study sponsor or research team.

Caigang Liu, Dr.

CONTACT

[email protected]

18940254967

Nan Niu, Dr.

CONTACT

[email protected]

18940256668

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Dec 12, 2023
Registry last updated
Jan 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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