Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of TNBC-BM.

NCT07638852 | Recruiting Phase 2 DMC

• 1 other identifier: 2510331-6
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Metastasases; TNBC, Triple Negative Breast Cancer

Keywords

TNBC; brain metastatic; radiotherapy; Bevacizumab; adebrelimab

Outcome Measures

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.

  From randomization up to 12 months.

Secondary Outcomes (16)

• CNS ORR

  Up to 24 months(Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

• CNS CBR

  Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

• ORR

  Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

• CBR

  Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)

• DoR

  From first documented response to progression or death, assessed up to 24 months

Other Outcomes (1)

• Exploratory Biomarker Analysis

  At baseline, after Cycle 2 (each cycle is 21 days), and at disease progression or treatment discontinuation (up to 24 months)

Study Arms (2)

Radiotherapy followed by systemic therapy group

EXPERIMENTAL

Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin.

Radiation: Radiation Therapy; Drug: Adebelimab; Drug: Bevacizumab; Drug: Cisplatin or carboplatin

Systemic therapy followed by radiotherapy group

EXPERIMENTAL

Patient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy.

Radiation: Radiation Therapy; Drug: Adebelimab; Drug: Bevacizumab; Drug: Cisplatin or carboplatin

Interventions

Radiation Therapy RADIATION

Patients will receive either Fractionated Stereotactic Radiotherapy (FSRT) or Whole Brain Radiotherapy (WBRT), at the discretion of the treating physician based on the number, size, and location of brain metastases.

Radiotherapy followed by systemic therapy group; Systemic therapy followed by radiotherapy group

Adebelimab DRUG

20mg/kg, IV, D1, Q3W

Radiotherapy followed by systemic therapy group; Systemic therapy followed by radiotherapy group

Bevacizumab DRUG

7.5mg/kg, IV, D1, Q3W

Radiotherapy followed by systemic therapy group; Systemic therapy followed by radiotherapy group

Cisplatin or carboplatin DRUG

Cisplatin 75mg/m2, IV, D1, Q3W; or carboplatin: AUC=5, IV, D1, Q3W

Radiotherapy followed by systemic therapy group; Systemic therapy followed by radiotherapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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 to confirm progression after radiotherapy.
• Provide sufficient fresh tissue specimens or tumor samples (primary lesion and/or metastatic lesions) ≥10 slides before treatment (preferably brain metastatic lesion specimens) for biomarker analysis.
• \. Patients receiving mannitol, corticosteroids, or anticonvulsants prior to the first dose are eligible for enrollment if the doses of these concomitant medications have been stable for at least 1 week without escalation, and neurological symptoms have remained stable for ≥1 week.
• \. 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; 10. Voluntary participation in this study, signing informed consent, good adherence, and willingness to cooperate with follow-up.

You may not qualify if:

• 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;
• A known history of allergy to any component of the medications in this regimen;
• A history of immunodeficiency, including a positive HIV test, active hepatitis B/C, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• A history of a defined neurological or psychiatric disorder, including epilepsy or dementia;
• Pregnant or lactating women, women of childbearing age with a positive baseline pregnancy test, or patients who do not wish to use effective contraception throughout the trial;
• In the investigator's judgment, a serious comorbidity that would jeopardize patient safety or affect the patient's ability to complete the study (including but not limited to severe hypertension uncontrolled by medication, severe diabetes, active infection, thyroid disease, etc.);
• Any other circumstances deemed unsuitable for participation in this study by the investigator.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Radiotherapy; Bevacizumab; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: June 10, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)