TNBC, Triple Negative Breast CancerPhase 2ABC-RNCT07638852
Study of Radiotherapy Combined With Cisplatin/Carboplatin, Adebrelimab and Bevacizumab in the Treatment of TNBC-BM.
A Phase 2 study testing Radiation Therapy, Adebelimab and Bevacizumab in people with TNBC, Triple Negative Breast Cancer and Brain Metastasases, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- TNBC, Triple Negative Breast Cancer, Brain Metastasases
- What is being tested?
- Radiation Therapy, Adebelimab and Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 9. 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.
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Ting LI, +86 13917792964, cinderellaliting@126.com
About this study
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
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.
- Being tested
- Radiation Therapy, Adebelimab, Bevacizumab, Cisplatin or carboplatin
- Keywords
- TNBC, brain metastatic, radiotherapy, Bevacizumab, adebrelimab
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
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.
AdebelimabDrug
20mg/kg, IV, D1, Q3W
BevacizumabDrug
7.5mg/kg, IV, D1, Q3W
Cisplatin or carboplatinDrug
Cisplatin 75mg/m2, IV, D1, Q3W; or carboplatin: AUC=5, IV, D1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy followed by systemic therapy group | Experimental | Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin. Receives: 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. Receives: Radiation: Radiation Therapy; Drug: Adebelimab; Drug: Bevacizumab; Drug: Cisplatin or carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization up to 12 months.
Secondary outcomes (16)
CNS ORR
ntracranial objective response rate is defined as the proportion of patients who achieve a best overall intracranial response of complete response (CR) or partial response (PR), as assessed by RANO-BM criteria.
Measured: Up to 24 months(Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
CNS CBR
Clinical benefit rate is defined as the proportion of patients who achieve a best overall intracranial response of complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 24 weeks, as assessed by RANO-BM criteria.
Measured: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
ORR
Objective response rate is defined as the proportion of patients who achieve a best overall response of complete response (CR) or partial response (PR)
Measured: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
CBR
clinical benefit rate is defined as the proportion of patients who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 24 weeks.
Measured: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
DoR
Duration of response is defined as the time from first documented objective response (CR or PR) until disease progression or death from any cause, whichever occurs first.
Measured: From first documented response to progression or death, assessed up to 24 months
CNS PFS
Intracranial progression-free survival is defined as the time from treatment initiation until intracranial disease progression per RANO-BM criteria or death from any cause, whichever occurs first.
Measured: From randomization to intracranial progression or death, assessed up to 24 months.
PFS
Progression-free survival is defined as the time from treatment initiation to disease progression or death from any cause, whichever occurs first.
Measured: From randomization to progression or death, assessed up to 24 months.
OS
Overall survival is defined as the time from the start of treatment to death from any cause.
Measured: From randomization to death, assessed up to 24 months.
Adverse Events (AE)
Adverse events will be assessed and graded according to NCI-CTCAE version 5.0.
Measured: From randomization through 30 days after the last dose of study treatment, assessed up to 24 months.
Hopkins Verbal Learning Test-Revised (HVLT-R)
Neurocognitive function assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R).
Measured: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Quality of life assessed using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire.
Measured: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
Mini-Mental State Examination (MMSE)
Neurocognitive function assessed using the Animal Verbal Fluency Test.
Measured: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Animal Verbal Fluency Test
Animal Oral Vocabulary Association Test
Measured: 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.
Trail Making Test (TMT-A/TMT-B)
Neurocognitive function assessed using the Trail Making Test (TMT-A/TMT-B)
Measured: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
EORTC QLQ-C30
Quality of life assessed using the EORTC Core Quality of Life Questionnaire (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.
Measured: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
EORTC QLQ-BN20
Quality of life assessed using the EORTC Quality of Life Questionnaire for Brain Neoplasms (QLQ-BN20). This 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.
Measured: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start2 Feb 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC, Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638852
- Sponsor's protocol ID
- 2510331-6
- Acronym
- ABC-R
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07638852
- Acronym / sponsor ID
- ABC-R / 2510331-6
- Keywords
- TNBC, brain metastatic, radiotherapy, Bevacizumab, adebrelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy followed by systemic therapy group | Experimental | Radiation: Radiation Therapy, Drug: Adebelimab, Drug: Bevacizumab, Drug: Cisplatin or carboplatinPatient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin. |
| Systemic therapy followed by radiotherapy group | Experimental | Radiation: Radiation Therapy, Drug: Adebelimab, Drug: Bevacizumab, Drug: Cisplatin or carboplatinPatient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyPatients 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. | Radiation | Radiotherapy followed by systemic therapy group, Systemic therapy followed by radiotherapy group |
| Adebelimab20mg/kg, IV, D1, Q3W | Drug | Radiotherapy followed by systemic therapy group, Systemic therapy followed by radiotherapy group |
| Bevacizumab7.5mg/kg, IV, D1, Q3W | Drug | Radiotherapy followed by systemic therapy group, Systemic therapy followed by radiotherapy group |
| Cisplatin or carboplatinCisplatin 75mg/m2, IV, D1, Q3W; or carboplatin: AUC=5, IV, D1, Q3W | Drug | Radiotherapy followed by systemic therapy group, Systemic therapy followed by radiotherapy group |
Primary outcome
12-month CNS-PFS rate
Time frame: From randomization up to 12 months.
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.
16 secondary outcomes
CNS ORR
Time frame: Up to 24 months(Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
CNS CBR
Time frame: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
ORR
Time frame: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
CBR
Time frame: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
DoR
Time frame: From first documented response to progression or death, assessed up to 24 months
CNS PFS
Time frame: From randomization to intracranial progression or death, assessed up to 24 months.
PFS
Time frame: From randomization to progression or death, assessed up to 24 months.
OS
Time frame: From randomization to death, assessed up to 24 months.
Adverse Events (AE)
Time frame: From randomization through 30 days after the last dose of study treatment, assessed up to 24 months.
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Time frame: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
Mini-Mental State Examination (MMSE)
Time frame: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Animal Verbal Fluency Test
Time frame: 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.
Trail Making Test (TMT-A/TMT-B)
Time frame: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
EORTC QLQ-C30
Time frame: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
EORTC QLQ-BN20
Time frame: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation Therapy, Adebelimab and Bevacizumab in people with TNBC, Triple Negative Breast Cancer and Brain Metastasases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month CNS-PFS rate (time frame: From randomization up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.