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Focused Ultrasound Ablation Remodels the Tumor Immune Microenvironment in Residual Triple-Negative Breast Cancer following Neoadjuvant Therapy

Focused Ultrasound Ablation Remodels the Tumor Immune Microenvironment in Residual Triple-Negative Breast Cancer following Neoadjuvant Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113385
Enrollment
Unknown
Registered
2025-11-27
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Triple-negative breast cancer

Interventions

Control Arm:Standard Surgical Therapy
FUAS Intervention Arm:Focused Ultrasound Ablation Surgery

Sponsors

Lishui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Patients with pathologically confirmed TNBC, with a pre-neoadjuvant therapy tumor stage of cT1-3N1-2M0; 2.Completion of a standard regimen of neoadjuvant therapy. 3.Confirmed non-pCR status assessed by MRI, ultrasound evaluation, and needle biopsy; 4.Single residual tumor diameter < 5 cm. 5.Good function of vital organs. 6.Residual tumor lesion is visible on ultrasound, with clear boundaries, located at least 1.0 cm from the skin or chest wall, and at least 2 cm from the nipple.

Exclusion criteria

Exclusion criteria: 1.Presence of detected metastases in bone, lung, brain, or other sites. 2.Coagulation dysfunction, myocardial diseases, uncontrolled diabetes mellitus, or other complex comorbidities. 3.Allergy to MRI contrast agents or ultrasound microbubble contrast agents.

Design outcomes

Primary

MeasureTime frame
pCR: pTis/0N0;

Secondary

MeasureTime frame
Postoperative adverse reactions of FUS ablation;

Countries

China

Contacts

Public ContactCai Shibin

Lishui Central Hospital

csb.china@qq.com+86 578 2285331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026