OncoMatch/Clinical Trials/NCT07394218
ctDNA-guided Treatment Decision-making
Is NCT07394218 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including ADC and Ivonescimab for metastatic breast cancer ( her2 negative).
Treatment: ADC · Ivonescimab — This is an exploratory, ctDNA-guided, multi-stage clinical study designed to evaluate the clinical value of treatment decision-making based on circulating tumor DNA (ctDNA) variant allele frequency (VAF) dynamics in patients with HER2-negative metastatic breast cancer. All enrolled patients will receive antibody-drug conjugate (ADC) therapy for two cycles in Stage 1, with serial ctDNA assessments performed prior to Cycle 1 and Cycle 2. In Stage 2, patients without disease progression will be assigned to different treatment strategies based on the percentage reduction in mean ctDNA VAF. The study aims to assess whether ctDNA VAF dynamics can serve as an early biomarker to guide treatment intensification and improve clinical outcomes in metastatic breast cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antibody-drug conjugate
Exception: targeting the same antigen and payload
Prior treatment with ADC targeting the same antigen and payload
Lab requirements
Blood counts
Adequate organ and bone marrow function
Kidney function
Adequate organ and bone marrow function
Liver function
Adequate organ and bone marrow function
Adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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