Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases.
This is a prospective, single-arm, single-center, Simon's two-stage design, phase II clinical trial in triple-negative breast cancer brain metastases patients. Subjects will receive bevacizumab,SHR1316 combined with cisplatin/carboplatin,and will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, or investigators determine that medication must be discontinued. Drug efficacy and safety data will be collected.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGOverall Response Rate in the CNS
CNS ORR will be assessed by the investigator according to RANO-BM criteria. According to these criteria Complete Response (CR) will be defined as the disappearance of all CNS target lesions sustained for at least 4 weeks; no new lesions, no corticosteroids; stable or improved clinically. Partial Response (PR) will be defined as a decrease of at least 30% in the sum longest diameter (LD) of CNS target lesions, taking as reference the baseline sum LD, sustained for at least 4 weeks; no new lesions; no corticosteroids; stable or improved clinically.
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
Clinical Benefit Rate in the CNS
CNS clinical benefit rate (CBR) will be defined as the percentage of patients who experience a CR, PR or Stable Disease (SD) for at least 24 weeks.
Time frame: from enrollment to progression or death (for any reason), assessed up to 24 months
Progression-free survival
PFS will be defined as the time from the first dose of treatment to death or disease progression.
Time frame: Up to 2 years
Overall survival
OS will be defined as the time from the first dose of treatment to death for any cause.
Time frame: Up to 2 years
First progression site
The first lesion to progress.
Time frame: Up to 2 years
Safety as assessed by percentage of patients with any Adverse Event
Adverse event according to NCI-CTC AE 5.0
Time frame: Up to 2 years
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