OncoMatch/Clinical Trials/NCT04303988
A Phase II Study of Triple-negative Breast Cancer Brain Metastases.
Is NCT04303988 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT04303988 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior platinum-based chemotherapy, whole brain radiotherapy, chemotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 wild-type is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR wild-type is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages