A Phase 2 interventional study of SHR-1316 and Bevacizumab in Breast Cancer, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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with cisplatin/carboplatin,and will be treated until disease progression, toxicity is intolerable, informed consent is withdrawn, or investigators determine that medication must be discontinued.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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 35 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.
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(1)Blood routine ANC≥1.5×109/L; PLT≥75×109/L; Hb≥90 g/L(Allows blood transfusion or the use of medication to ensure that the content of hemoglobin) (2)Coagulation: INR≤1.5,APTT≤1.5×ULN, PT does not exceed the upper limit of normal (3)Blood biochemistry TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN); Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula) (4)Cardiac ultrasound: LVEF≥50%; (5)12-lead ECG: females QTcF interval \<470msec and males \<450ms; 8.Willing to join the study, sign informed consent, have good compliance and cooperate with follow-up.
Exclusion Criteria:
Hormone receptor negative, HER2 negative participants will receive SHR1316 in combination with bevacizumab plus cisplatin or carboplatin until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Drug: SHR-1316 · Drug: Bevacizumab · Drug: Cisplatin/Carboplatin
IV
Also known as: HTI-1088
IV
Also known as: Avastin
Drug pages: Cisplatin · Carboplatin
IV
Also known as: Bobei
Overall 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
Plan to share: No
This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Adebrelimab · Bevacizumab · Cisplatin · Carboplatin