ctDNA-guided Treatment Decision-making

Sponsor
Fudan University
Study ID
NCT07394218
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Breast Cancer ( HER2 Negative)
  • ctDNA

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ADC — DRUG
    ADC therapy includes sacituzumab govitecan or trastuzumab deruxtecan administered intravenously according to standard dosing schedules. ADC treatment is given in all study stages and continued until disease progression or unacceptable toxicity.
  • Ivonescimab — DRUG
    Ivonescimab is administered intravenously at 20 mg/kg every 3 weeks in combination with ADC therapy for patients assigned to the combination treatment arm.

Study Details

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.

Key Dates

Start date
Dec 24, 2025
Status verified
Dec 2025
Primary completion
Mar 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
122 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ADC + Ivonescimab
    Patients with \<50% mean ctDNA VAF reduction receive ADC combined with ivonescimab.
  • Active Comparator: ADC Monotherapy
    Patients with \<50% mean ctDNA VAF reduction receive continued ADC monotherapy.
  • Active Comparator: ADC Monotherapy (ctDNA responder cohort)
    Patients with ≥50% mean ctDNA VAF reduction continue ADC monotherapy.

Primary Outcome Measure

Progression-Free Survival (PFS) in TNBC (Group A vs Group B) [ Time Frame: From randomization until progression or death (up to 36 months) ]

Central Contacts

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