OncoMatch/Clinical Trials/NCT07653893
A Phase II Observational Clinical Study on the Relationship Between Cerebrospinal Fluid Drug Concentration and Efficacy of Trastuzumab Deruxtecan in Central Nervous System Metastatic Breast Cancer
Is NCT07653893 recruiting? Yes, currently enrolling (Jul 2026).
Approximately 5-15% breast cancer patients develop brain metastases. Current local treatments (surgery/radiotherapy) are associated with significant complications, and systemic treatments have limited efficacy. Although new-generation ADC drugs, such as trastuzumab deruxtecan, have demonstrated breakthrough efficacy in patients with brain metastases, the mechanisms of action are not fully elucidated, moreover the current treatment regimens still have limitations for patients with HER2-low expressing, safer and more effective systemic treatment options are urgently needed to improve patient survival. BCBM-006 is an open-label, prospective, single-arm, single-center Phase II clinical study to evaluate the relationship between cerebrospinal fluid drug concentration and efficacy of trastuzumab deruxtecan in central nervous system metastatic breast cancer, and explore the incidence of leptomeningeal metastases diagnosed via lumbar puncture in patients with brain parenchymal metastases, facilitate early intervention to improve prognosis.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-HER2 antibody-drug conjugate with same payload
Exception: patients who discontinued prior ADC therapy for reasons other than resistance (e.g., toxicity) are eligible
Previous treatment with an anti-HER2 ADC drug carrying the same payload resulting in resistance. Patients who discontinued prior ADC therapy for other reasons, including but not limited to toxicity, are eligible.
Lab requirements
Blood counts
ANC≥1.5×10^9/L; PLT≥75×10^9/L; Hb≥90 g/L (allowing blood transfusion or medication to ensure hemoglobin content)
Kidney function
Creatinine ≤1.5 × ULN or Creatinine Clearance ≥50 mL/min (Cockcroft-Gault formula)
Liver function
TBIL≤1.5×ULN; ALT and AST≤3×ULN (≤ 5.0×ULN for liver metastases)
Cardiac function
LVEF ≥50%; Fridericia-corrected QT interval (QTcF) <470 ms for females, <450 ms for males
Organ function levels must meet the following requirements: Hematology: ANC≥1.5×10^9/L; PLT≥75×10^9/L; Hb≥90 g/L; Coagulation: APTT≤1.5×ULN; PT≤1.5×ULN; Blood Chemistry: TBIL≤1.5×ULN; ALT and AST≤3×ULN (≤ 5.0×ULN for liver metastases); Creatinine ≤1.5 × ULN or Creatinine Clearance ≥50 mL/min; Cardiac Ultrasound: LVEF ≥50%; 12-Lead ECG: QTcF <470 ms for females, <450 ms for males
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07653893 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-HER2 antibody-drug conjugate with same payload disqualifies patients from enrollment.
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 qualify