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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITING12-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.
Time frame: From randomization up to 12 months.
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.
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
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.
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
Objective response rate is defined as the proportion of patients who achieve a best overall response of complete response (CR) or partial response (PR)
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
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.
Time frame: Up to 24 months (Efficacy assessments at 6 weeks post-treatment initiation, followed by every 9 weeks thereafter starting from Month 12)
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Cisplatin 75mg/m2, IV, D1, Q3W; or carboplatin: AUC=5, IV, D1, Q3W
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
Neurocognitive function assessed using the 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)
Quality of life assessed using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire.
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)
Neurocognitive function assessed using the Animal Verbal Fluency Test.
Time frame: 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
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)
Neurocognitive function assessed using the 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
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.
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
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.
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