OncoMatch/Clinical Trials/NCT04303988
A Phase II Study of Triple-negative Breast Cancer Brain Metastases.
Is NCT04303988 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including SHR-1316 and Bevacizumab for breast cancer.
Treatment: SHR-1316 · Bevacizumab · Cisplatin/Carboplatin — Study to assess the effectiveness and safety of SHR 1316, bevacizumab combined with cisplatin/carboplatin for treatment of triple-negative breast cancer brain metastases.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 wild-type (<1%)
HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is <1%
Required: PR (PGR) wild-type (<1%)
HR negative is defined as: ER-negative and PR-negative, the proportion of positively stained tumor cells in all tumor cells is <1%
Required: HER2 (ERBB2) wild-type (IHC 0 or 1+ or 2+ and FISH(-))
HER2- negative is defined as: histologically confirmed to be HER2 IHC (0) or HER2 IHC(1+) or HER2 IHC (2+) and FISH(-)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: platinum-based chemotherapy
Exception: no platinum drugs have been used before, or platinum drugs have been used (cisplatin/carboplatin only one regimen) and platinum sensitive: no progression during at least 4 cycles of treatment, more than 3 months period between last platinum regimen and the progression of disease
It is required that no platinum drugs have been used before, or platinum drugs have been used (cisplatin/carboplatin only one regimen) and platinum sensitive: no progression during at least 4 cycles of treatment, more than 3 months period between last platinum regimen and the progression of disease
Cannot have received: whole brain radiotherapy
Exception: within 14 days prior to enrollment
Whole brain radiotherapy, chemotherapy or surgery within 14 days prior to enrollment
Cannot have received: chemotherapy
Exception: within 14 days prior to enrollment
Whole brain radiotherapy, chemotherapy or surgery within 14 days prior to enrollment
Cannot have received: surgery
Exception: within 14 days prior to enrollment
Whole brain radiotherapy, chemotherapy or surgery within 14 days prior to enrollment
Cannot have received: targeted therapy
Exception: within the previous week
Has received prior therapy with Targeted therapy or Endocrine therapy within the previous week
Cannot have received: endocrine therapy
Exception: within the previous week
Has received prior therapy with Targeted therapy or Endocrine therapy within the previous week
Cannot have received: anti-VEGF therapy (bevacizumab)
Subjects with HR-/HER2- who has received prior therapy with bevacizumab or PD-1/PD-L1
Cannot have received: anti-PD-1/PD-L1 therapy
Subjects with HR-/HER2- who has received prior therapy with bevacizumab or PD-1/PD-L1
Cannot have received: anti-cancer drugs
Exception: concurrent use
Concurrent use of any other Anti-cancer drugs
Lab requirements
Blood counts
ANC≥1.5×10^9/L; PLT≥75×10^9/L; Hb≥90 g/L (allows blood transfusion or the use of medication to ensure that the content of hemoglobin)
Kidney function
Urea nitrogen ≤ 1.5 × ULN; Cr≤1.5 × ULN or creatinine clearance ≥50 mL / min (Cockcroft-Gault formula)
Liver function
TBIL≤1.5 × ULN; ALT and AST≤3 × ULN (liver metastasis≤5.0 × ULN)
Cardiac function
LVEF≥50%; 12-lead ECG: females QTcF interval <470msec and males <450ms
Adequate function of major organs meets the following requirements: (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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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