MedTrace Logo

Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer.

NCT07394387 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2026-05-15

No results posted yet for this study

Summary

Background:

Triple-negative breast cancer (TNBC) is an aggressive type of breast cancer with limited treatment options. Research suggests that using High-Intensity Focused Ultrasound (HIFU) to destroy the tumor and/or PD-1 inhibitor drugs to activate the immune system before starting chemotherapy may improve treatment effectiveness. This study aims to investigate this new approach.

Objective:

To evaluate the effectiveness and safety of using HIFU, with or without a PD-1 inhibitor (Sintilimab), before and during combination chemotherapy in patients with early-stage TNBC. The primary goal is to determine if this strategy can increase the rate of pathological complete response (pCR).

Study Design:

This is a single-center, Phase II clinical study. Approximately 40 participants with Stage II-III TNBC will be enrolled and assigned to one of two groups (cohorts) without randomization:

Cohort A: Receives HIFU treatment. Two weeks later, begins standard chemotherapy (Abraxane and carboplatin) combined with the PD-1 inhibitor Sintilimab for 6 cycles.

Cohort B: Receives HIFU treatment combined with a single dose of the PD-1 inhibitor Sintilimab. Two weeks later, begins the same 6 cycles of chemotherapy (Abraxane and carboplatin) combined with Sintilimab.

Main Measures:

The primary measure is the rate of pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes after surgery following the completion of neoadjuvant therapy.

Other important measures include:

The ability of the treatment to activate the immune system (measured by changes in CD8+ T cells or IFN-γ).

The percentage of patients whose tumors shrink significantly (Objective Response Rate).

How long patients live without their cancer getting worse (Event-Free Survival).

The rate of patients who can undergo breast-conserving surgery. The frequency and severity of side effects.

Conditions

  • Triple Negative Breast Cancer (TNBC)

Interventions

DRUG

Sintilimab

200 mg, administered intravenously every 3 weeks.

DRUG

Abraxane

260 mg/m², administered intravenously on Day 1 of each 21-day cycle.

DRUG

Carboplatin

AUC = 6, administered intravenously on Day 1 of each 21-day cycle.

PROCEDURE

High-intensity focused ultrasound (HIFU)

HIFU sparse scanning. Under ultrasound guidance, the tumor and a 5mm margin of surrounding normal tissue are ablated using a point-by-point protocol (150W power, 3s irradiation per point, 5mm point spacing). Performed once.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07394387 on ClinicalTrials.gov