RecruitingPhase 2NCT07394218

ctDNA-guided Treatment Decision-making

Study on ctDNA-guided Treatment Decision-making for HER2-negative Metastatic Breast Cancer


Sponsor

Fudan University

Enrollment

122 participants

Start Date

Dec 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether using a blood test called ctDNA (circulating tumor DNA) to detect traces of cancer in the bloodstream can guide treatment decisions for people with HER2-negative metastatic breast cancer who are candidates for antibody-drug conjugate (ADC) therapy. The idea is that real-time tumor monitoring may allow more personalized treatment adjustments. **You may be eligible if...** - You are 18 to 75 years old with a good performance status - You have HER2-negative metastatic breast cancer confirmed by biopsy - You are eligible for ADC therapy - You have at least one measurable tumor - You are willing to provide tumor tissue and blood samples **You may NOT be eligible if...** - You have previously received an ADC targeting the same cancer protein - You have had severe immune-related side effects (grade 3 or higher) from prior immunotherapy - You have active or untreated brain metastases - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGADC

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.

DRUGIvonescimab

Ivonescimab is administered intravenously at 20 mg/kg every 3 weeks in combination with ADC therapy for patients assigned to the combination treatment arm.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07394218


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