Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
NCT07394387

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-03-19

39

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 65 years
  • Histologically confirmed invasive Stage II-III triple-negative breast cancer
  • At least one measurable tumor lesion according to RECIST v1.1
  • No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer
  • ECOG performance status of 0 or 1
  • Adequate organ function including specific blood counts and liver, kidney tests within set limits
  • Adequate cardiac function with no ischemia, NYHA class I, normal echocardiogram and cardiac markers
  • Normal thyroid function
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Male patients or inflammatory breast cancer
  • Metastatic (Stage IV) breast cancer
  • Active autoimmune or inflammatory diseases requiring systemic treatment within past 2 years (some exceptions apply)
  • Other concurrent or recent malignancies within past 5 years except certain skin or cervical cancers
  • Serious non-malignant diseases that risk compliance or safety
  • Major surgery within 4 weeks prior or planned during study
  • Prior breast cancer treatments including radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major surgery
  • Known allergies to study drugs
  • Poorly controlled cardiac disease or recent heart events
  • History or current interstitial lung disease
  • Active infections including HIV, tuberculosis, hepatitis B or C
  • Active autoimmune disease requiring systemic treatment
  • Cognitive or psychiatric conditions impairing consent understanding
  • Unhealed wounds, ulcers, fractures within 4 weeks or significant bleeding history
  • Any other condition judged unsuitable by the investigator

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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