Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

3 de septiembre de 2026 actualizado por: Jian Zhang,MD, Fudan University

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

58

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200032
        • Reclutamiento
        • Fudan University Shanghai Cancer Center
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 to confirm progression after radiotherapy.
  7. 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.

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Radiotherapy followed by systemic therapy group
Patient who are eligible for inclusion will recieve radiotherapy first, followed by adebrelimab, bevacizumab and Cisplatin/Carplatin.
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.
20mg/kg, IV, D1, Q3W
7.5mg/kg, IV, D1, Q3W
Cisplatin 75mg/m2, IV, D1, Q3W; or carboplatin: AUC=5, IV, D1, Q3W
Experimental: Systemic therapy followed by radiotherapy group
Patient who are eligible for inclusion will recieve adebrelimab, bevacizumab and Cisplatin/Carplatin followed by radiotherapy.
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.
20mg/kg, IV, D1, Q3W
7.5mg/kg, IV, D1, Q3W
Cisplatin 75mg/m2, IV, D1, Q3W; or carboplatin: AUC=5, IV, D1, Q3W

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
12-month CNS-PFS rate
Periodo de tiempo: 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.
From randomization up to 12 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
CNS ORR
Periodo de tiempo: Up to 24 months(Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
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.
Up to 24 months(Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
CNS CBR
Periodo de tiempo: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
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.
Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
ORR
Periodo de tiempo: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
Objective response rate is defined as the proportion of patients who achieve a best overall response of complete response (CR) or partial response (PR)
Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
CBR
Periodo de tiempo: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
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.
Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
DoR
Periodo de tiempo: From first documented response to progression or death, assessed up to 24 months
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.
From first documented response to progression or death, assessed up to 24 months
CNS PFS
Periodo de tiempo: From randomization to intracranial progression or death, assessed up to 24 months.
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.
From randomization to intracranial progression or death, assessed up to 24 months.
PFS
Periodo de tiempo: From randomization to progression or death, assessed up to 24 months.
Progression-free survival is defined as the time from treatment initiation to disease progression or death from any cause, whichever occurs first.
From randomization to progression or death, assessed up to 24 months.
OS
Periodo de tiempo: From randomization to death, assessed up to 24 months.
Overall survival is defined as the time from the start of treatment to death from any cause.
From randomization to death, assessed up to 24 months.
Adverse Events (AE)
Periodo de tiempo: From randomization through 30 days after the last dose of study treatment, assessed up to 24 months.
Adverse events will be assessed and graded according to NCI-CTCAE version 5.0.
From randomization through 30 days after the last dose of study treatment, assessed up to 24 months.
Hopkins Verbal Learning Test-Revised (HVLT-R)
Periodo de tiempo: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Neurocognitive function assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R).
At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Periodo de tiempo: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
Quality of life assessed using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire.
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)
Periodo de tiempo: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Neurocognitive function assessed using the Animal Verbal Fluency Test.
At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Animal Verbal Fluency Test
Periodo de tiempo: 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.
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.
Trail Making Test (TMT-A/TMT-B)
Periodo de tiempo: At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
Neurocognitive function assessed using the Trail Making Test (TMT-A/TMT-B)
At screening, 12, 24, 36, 48 weeks, 1.5 years, and 2 years after radiotherapy completion
EORTC QLQ-C30
Periodo de tiempo: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
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.
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
Periodo de tiempo: At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months
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.
At screening, within 3 days before each cycle of treatment, and at end of treatment or safety follow-up, assessed up to 24 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Exploratory Biomarker Analysis
Periodo de tiempo: At baseline, after Cycle 2 (each cycle is 21 days), and at disease progression or treatment discontinuation (up to 24 months)
Tumor tissue (≥10 unstained slides or fresh tissue specimens), blood (8 mL of clotted blood, 8 mL of anticoagulated blood), cerebrospinal fluid (8 mL), urine (20 mL ), and stool samples (5 g) will be collected for exploratory cytological and multi-omics analyses to identify biomarkers associated with treatment response and resistance to radiotherapy combined with systemic therapy.
At baseline, after Cycle 2 (each cycle is 21 days), and at disease progression or treatment discontinuation (up to 24 months)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de febrero de 2026

Finalización primaria (Estimado)

30 de junio de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

26 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir