Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)
DrugAdebrelimab 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)
Drugadebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: adebrelimab plus stereotactic radiotherapy and chemotherapyExperimental treatment 1 intervention
Group B: adebrelimab plus nab-paclitaxel + carboplatinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
tpCR
total pathologic complete response
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov