Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of TNBC-BM. (NCT07638852) | Clinical Trial Compass
RecruitingPhase 2
Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of TNBC-BM.
China58 participantsStarted 2026-02-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
. Expected survival ≥8 weeks;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
12-month CNS-PFS rate
Timeframe: From treatment initiation to 12 months.
. MRI confirms brain metastasis, with at least one previously untreated intracranial brain parenchymal metastatic lesion with a longest diameter ≥1.0 cm;If the brain metastatic lesion has previously undergone radiotherapy, MRI is required.
. Confirm progression after radiotherapy;
. Provide sufficient fresh tissue specimens or tumor samples (primary lesion and/or metastatic lesions) ≥10 smears before treatment (preferably brain metastatic lesion specimens) for biomarker analysis.
Exclusion criteria
. 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;
. Participation in other drug clinical trials within 2 weeks prior to enrollment;
. Concurrent anti-tumor treatment for any other tumor;
. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
. History of any heart disease, including: (1) arrhythmia requiring medication or of clinical significance; (2) myocardial infarction; (3) heart failure; (4) any other heart disease deemed unsuitable for participation in this trial by the investigator;