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NCT06165900RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 3 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
136 (estimated)
First submitted
6 Oct 2023
Start date
26 Sept 2023
Primary completion date
15 Dec 2025
Lead sponsor
Shengjing Hospital
NCT number
NCT06165900

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 136
  • From 26 Sept 2023 to the primary completion date, 15 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • Patients with metastatic breast cancer or bilateral breast cancer;
  • Patients with inflammatory breast cancer or occult breast cancer;
  • 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.

Age

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shengjing Hospital Of China Medical University
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.