OncoMatch/Clinical Trials/NCT07638852
Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of TNBC-BM.
Official title: A Prospective, Two-arm, Multi-centre, Phase II Clinical Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of Patients With Brain Metastasis From Triple-Negative Breast Cancer
Is NCT07638852 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Adebelimab and Bevacizumab for tnbc, triple negative breast cancer.
Treatment: Adebelimab · Bevacizumab · Cisplatin or carboplatin — This is an open-label, prospective, two-arm, multicenter phase II clinical trial. The aim is to explore the efficacy and safety of radiotherapy combined with cisplatin/carboplatin, adebrelimab, and bevacizumab in patients with triple-negative breast cancer and brain metastases.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) wild-type (absence)
Required: ESR1 wild-type (absence)
Required: PR (PGR) wild-type (absence)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: platinum-based chemotherapy (cisplatin, carboplatin)
Exception: must have previously used only one regimen and meet platinum sensitivity definition: no progression during at least 4 cycles, and subsequent disease progression >3 months after last platinum-based therapy
Must not have previously used platinum-based drugs, or must have previously used platinum-based drugs (cisplatin or carboplatin and only one regimen) and meet the following definition of platinum sensitivity: no progression during at least 4 cycles of platinum-based therapy, and subsequent disease progression occurring more than 3 months after the last platinum-based therapy
Cannot have received: bevacizumab (bevacizumab)
Exception: no disease progression during bevacizumab use, no drug resistance confirmed, continued use would benefit subject; short-term bevacizumab use to relieve cerebral edema
Previous use of bevacizumab...excluding the following: no disease progression during bevacizumab use, investigators believe no drug resistance has been confirmed, and continued use would benefit the subject; short-term bevacizumab use to relieve cerebral edema
Cannot have received: PD-1/PD-L1 inhibitor
Exception: no disease progression during PD-1/PD-L1 inhibitor use, no drug resistance confirmed, continued use would benefit subject
Previous use of PD-1/PD-L1 inhibitors, excluding the following: no disease progression during PD-1/PD-L1 inhibitor use, investigators believe no drug resistance has been confirmed, and continued use would benefit the subject
Lab requirements
Blood counts
ANC ≥1.5×10⁹/L; PLT ≥75×10⁹/L; Hb ≥90 g/L (blood transfusion or drug treatment is allowed to ensure hemoglobin levels)
Kidney function
Cr ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN (liver metastases ≤ 5.0 × ULN)
Cardiac function
LVEF ≥ 50%; 12-lead ECG: QTcF < 470 ms for women and < 450 ms for men
Organ function levels must meet the following requirements:1) Complete blood count:• ANC ≥1.5×10⁹/L;• PLT ≥75×10⁹/L;• Hb ≥90 g/L (blood transfusion or drug treatment is allowed to ensure hemoglobin levels);2) Coagulation function: INR ≤1.5, APTT ≤1.5×ULN; PT not exceeding the upper limit of normal.3) Blood Biochemistry: • TBIL ≤ 1.5 × ULN;• ALT and AST ≤ 3 × ULN (liver metastases ≤ 5.0 × ULN);• Cr ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);3) Echocardiography: LVEF ≥ 50%;4) 12-lead ECG: Fridricia-corrected QT interval (QTcF) < 470 ms for women and < 450 ms for men
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07638852 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior platinum-based chemotherapy, bevacizumab, PD-1/PD-L1 inhibitor disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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