Health Trials

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

ConditionsStereotactic RadiotherapyImmunotherapyBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShengjing Hospital

About this trial

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

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

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

Treatment groups

136 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shengjing Hospital

Lead sponsor

Source ClinicalTrials.gov