Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of TNBC-BM. (ABC-R)

A Prospective, Single-arm, Multi-centre, Phase II Clinical Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of Patients With Brain Metastasis of Triple Negativebreast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: TNBC, Triple Negative Breast Cancer; Brain Metastasases
• Intervention / Treatment: Drug: Radiotherapy followed by systemic therapy; Drug: Systemic therapy followed by radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Ting LI; Phone Number: +86 13917792964; Email: cinderellaliting@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years and ≤70 years, gender not limited;
2. ECOG score 0-2;
3. 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;
4. 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;
5. Expected survival ≥8 weeks;
6. 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.
7. Confirm progression after radiotherapy;
8. 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.
9. Use mannitol, hormones, or anticonvulsants before the first dose, but the drug treatment dose must be stable for at least one week without needing to be increased.Neurological symptoms stable for ≥1 week are required for enrollment.
10. 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.

Exclusion Criteria:

1. Leptomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;
2. Presence of third-space effusion (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;
3. 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;
4. 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;
5. Participation in other drug clinical trials within 2 weeks prior to enrollment;
6. Concurrent anti-tumor treatment for any other tumor;
7. 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;
8. 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;
9. A known history of allergy to any component of the medications in this regimen;
10. 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;
11. A history of a defined neurological or psychiatric disorder, including epilepsy or dementia;
12. 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;
13. 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.);
14. Any other circumstances deemed unsuitable for participation in this study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy followed by systemic therapy group; Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin.	Drug: Radiotherapy followed by systemic therapy; Radiotherapy followed by Adebrelimab+Bevacizumab+Cisplatin/Carboplatin
Experimental: Systemic therapy followed by radiotherapy group; Patient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy.	Drug: Systemic therapy followed by radiotherapy; Adebrelimab+Bevacizumab+Cisplatin/Carboplatin followed by radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 treatment initiation to 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CNS ORR	Intracranial objective response rate: Time elapsed from the start of treatment until the Intracranial tumor achieves objective response (PR or CR)	From treatment initiation until CNS progression, assessed up to 36 months.
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	From treatment initiation until CNS progression, assessed up to 36 months.
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.	From treatment initiation until disease progression, assessed up to 36 months.
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	From treatment initiation until disease progression, assessed up to 36 months.
DoR	Time from first remission to disease progression	From the date of first documented response until disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
CNS PFS	Intracranial progression-free survival: Time from the start of treatment to the patient's "progression of intracranial disease" or "death from any cause"	From treatment initiation until CNS progression or death from any cause, whichever occurs first, assessed up to 36 months.
PFS	The time from the start of treatment to the first observed disease progression or death from any cause.	From treatment initiation until disease progression or death from any cause, whichever occurs first, assessed up to 36months.
OS	Time from the start of treatment to death from any cause	From treatment initiation until death from any cause, assessed up to 36 months.
AE	AE, according to NCI-CTC AE 5.0	From first dose through 30 days after the last dose of study treatment, assessed up to 36 months.
Neurocognitive function assessment 1	Hopkins Oral Learning Test (HVLT)	From enrollment to the end of treatment at 24 months，evaluations were conducted at screening, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 1.5 years, and 2 years after completion of radiotherapy.
Quality of life assessment 1	Functional Assessment of Cancer Therapy - Brain (FACT-Br)	Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 36 months.
Neurocognitive function assessment 2	Mini-mental Test (MMSE)	From enrollment to the end of treatment at 24 months，evaluations were conducted at screening, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 1.5 years, and 2 years after completion of radiotherapy.
Neurocognitive function assessment 3	Animal Oral Vocabulary Association Test	From enrollment to the end of treatment at 24 months，evaluations were conducted at screening, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 1.5 years, and 2 years after completion of radiotherapy.
Neurocognitive function assessment 4	Connect-the-Dots Test (TMT-A/TMT-B)	From enrollment to the end of treatment at 24 months，evaluations were conducted at screening, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 1.5 years, and 2 years after completion of radiotherapy.
Quality of life assessment 2	The EORTC QLG Core Questionnaire (EORTC QLQ-C30), scoring from 0 to 100. This questionnaire is for functional and global quality of life scales, higher scores mean a better level of functioning. For symptom-oriented scales, a higher score means more severesymptoms.	Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 36 months.
Quality of life assessment 3	The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Brain Neoplasm (QLQ-BN20) aims to evaluate the effects of the tumour and its treatment on symptoms, functions and health-related quality of life (HRQoL) of brain tumour patients. The scale scoring form 0 to 100, and a higher score generally indicates more severe symptoms and poorer quality of life.	Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 36 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; Bevacizumab; TNBC; adebrelimab; brain metastatic
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 2510331-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. The informed consent states that participants' records will be kept in a locked filing cabinet and accessed only by the research team, with access granted to regulatory authorities or the ethics committee solely for on-site monitoring purposes. The consent does not include provision for sharing de-identified individual participant data with other researchers or depositing data in public repositories.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No