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NCT Number: NCT07394218

ctDNA-guided Treatment Decision-making

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.

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Key information

Conditions

Metastatic Breast Cancer ( HER2 Negative) Breast Diseases Breast Neoplasms CtDNA Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years；ECOG performance status 0-1； Histologically or cytologically confirmed HER2-negative metastatic breast cancer； At least one measurable lesion per RECIST v1.1； Eligible for ADC therapy； Adequate organ and bone marrow function； Life expectancy ≥3 months； Willingness to provide tumor tissue and blood samples； Signed informed consent

Exclusion criteria

  • Prior treatment with ADC targeting the same antigen and payload；History of grade ≥3 immune-related adverse events； Active or untreated CNS metastases； Active autoimmune disease requiring systemic therapy； Clinically significant cardiovascular disease； Active interstitial lung disease； Active infection including tuberculosis, HIV, hepatitis B or C； Pregnancy or breastfeeding；Investigator-determined conditions that may interfere with study participation

Treatment and study plan

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.

Primary outcomes

  1. Progression-Free Survival (PFS) in TNBC (Group A vs Group B)

    Time frame: From randomization until progression or death (up to 36 months)

    Time from randomization to disease progression or death, assessed by RECIST v1.1.

Secondary outcomes

  1. ORR (RECIST v1.1)，DoR，CBR，OS，Safety (CTCAE v5.0)

    Time frame: From treatment initiation until end of follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxia WANG

CONTACT

[email protected]

86-138196379

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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