Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of TNBC-BM.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University
About this trial
This is an open-label, prospective, single-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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years and ≤70 years, gender not limited;
ECOG score 0-2;
Pathologically confirmed HR-negative/HER2-negative breast cancer patients with evidence of local recurrence or metastasis, unsuitable for curative surgical resection or radiotherapy; HR-negative is defined as ER-negative and PR-negative, with positive tumor cells accounting for <10% of all tumor cells;
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;
Disqualifiers
Leptomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;
Presence of third-space effusion (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;
Received whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to treatment with the investigational drug, or received endocrine therapy within one week prior to treatment;
Previous use of bevacizumab and PD-1/PD-L1 inhibitors, excluding the following: no disease progression during bevacizumab and PD-1/PD-L1 inhibitor use, investigators believe no drug resistance has been confirmed, and continued use would benefit the subject; short-term bevacizumab use to relieve cerebral edema;
Trial design
Design model
Crossover
Treatments tested in this trial
Radiotherapy followed by systemic therapy
DrugRadiotherapy followed by Adebrelimab+Bevacizumab+Cisplatin/Carboplatin
Systemic therapy followed by radiotherapy
DrugAdebrelimab+Bevacizumab+Cisplatin/Carboplatin followed by radiotherapy.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Radiotherapy followed by systemic therapy groupExperimental treatment 1 intervention
Group B: Systemic therapy followed by radiotherapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12-month CNS-PFS rate
The 12-month CNS-PFS rate was used for intracranial efficacy assessment based on RANO-BM, and extracranial efficacy assessment based on RECIST 1.1.
Time frame
From treatment initiation to 12 months.Secondary outcomes
1
CNS ORR
Intracranial objective response rate: Time elapsed from the start of treatment until the Intracranial tumor achieves objective response (PR or CR)
Time frame
From treatment initiation until CNS progression, assessed up to 36 months.2
CNS CBR
This refers to the proportion of patients who achieve complete remission, partial remission, or stable disease for a certain period of time after receiving treatment: CR+ PR+ SD ≧ 24 weeks
Time frame
From treatment initiation until CNS progression, assessed up to 36 months.3
ORR
The proportion of patients who achieved partial response (PR) and complete remission (CR) after receiving a certain anti-tumor treatment, resulting in tumor shrinkage.
Time frame
From treatment initiation until disease progression, assessed up to 36 months.4
CBR
The proportion of patients who achieve complete remission, partial remission, or stable disease for a certain period of time after receiving treatment: CR+ PR+ SD ≧ 24 weeks
Time frame
From treatment initiation until disease progression, assessed up to 36 months.Other outcomes
1
cytological and multi-omics testing
Collect and preserve tumor samples (primary lesions and/or metastases, preferably brain metastases) ≥10 blotting sheets or fresh tissue specimens; collect 8 ml of procoagulant, 8 ml of anticoagulant, and 5 ml of cerebrospinal fluid from subjects at baseline, after C2, and at disease progression or upon exit from the study for cytological and multi-omics testing, exploratoryly investigating factors that may influence or predict the efficacy of radiotherapy combined with systemic therapy.
Time frame
These tests will be conducted at baseline, at the end of Cycle 2 (each cycle is 21 days), and at disease progression or when leaving the study, assessed up to 36 months.Sponsors and contacts
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Source ClinicalTrials.gov