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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Radiotherapy followed by Adebrelimab+Bevacizumab+Cisplatin/Carboplatin
Adebrelimab+Bevacizumab+Cisplatin/Carboplatin followed by radiotherapy.
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 treatment initiation to 12 months.
CNS ORR
Intracranial objective response rate: Time elapsed from the start of treatment until the Intracranial tumor achieves objective response (PR or CR)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: From treatment initiation until disease progression, assessed up to 36 months.
DoR
Time from first remission to disease progression
Time frame: From the date of first documented response until disease progression or death from any cause, whichever occurs first, assessed up to 36 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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"
Time frame: 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.
Time frame: 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
Time frame: From treatment initiation until death from any cause, assessed up to 36 months.
AE
AE, according to NCI-CTC AE 5.0
Time frame: 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)
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.
Quality of life assessment 1
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
Time frame: 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)
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.
Neurocognitive function assessment 3
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.
Neurocognitive function assessment 4
Connect-the-Dots Test (TMT-A/TMT-B)
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.
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.
Time frame: 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.
Time frame: Screening, within 3 days before each treatment administration, at the end of treatment, and during safety follow-up, assessed up to 36 months.