Focused ultrasound (HIFU) with or without a PD‑1 immune drug before Abraxane and carboplatin in triple‑negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center Phase II study will enroll about 40 patients with stage II–III triple‑negative breast cancer who have not had prior breast cancer treatment. Participants are non-randomly assigned to one of two cohorts: HIFU followed by standard chemotherapy (nab‑paclitaxel and carboplatin) or HIFU combined with the PD‑1 inhibitor sintilimab followed by the same chemotherapy. The primary endpoint is the pathological complete response (pCR) rate after neoadjuvant therapy, with safety and tolerability also monitored. Treatments are given before definitive surgery to determine whether adding HIFU and/or immunotherapy increases tumor eradication compared with historical expectations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients aged ≥18 and ≤70 years.
2. Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC TNM staging.
3. At least one measurable lesion as per RECIST v1.1 criteria.
4. No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.
5. ECOG performance status of 0 or 1.
6. Adequate organ function, defined as:

   * Hemoglobin ≥90 g/L
   * White blood cell count ≥3.5×10\^9/L
   * Platelet count ≥100×10\^9/L
   * Absolute neutrophil count ≥1.5×10\^9/L
   * AST and ALT ≤3× upper limit of normal (ULN)
   * Total bilirubin ≤1.5× ULN
   * Serum creatinine ≤1.5× ULN
   * No evidence of pneumonia on chest CT
7. Adequate cardiac function, defined as:

   * No myocardial ischemia on ECG
   * NYHA class I
   * LVEF ≥55% on echocardiogram
   * Normal cardiac markers (cTnI and BNP)
8. Normal thyroid function (T3, T4, FT3, FT4, TSH).
9. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Male or inflammatory breast cancer.
2. Metastatic (Stage IV) breast cancer.
3. History of active autoimmune or inflammatory diseases requiring systemic treatment within the past 2 years (e.g., systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis). Exceptions: type I diabetes, hypothyroidism controlled with hormone replacement therapy, or skin disorders not requiring systemic treatment (e.g., vitiligo, psoriasis).
4. Concurrent other malignancies or history of other malignancies within the past 5 years (except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix).
5. Any other serious non-malignant disease that may compromise compliance or place the patient at risk.
6. Major surgery within 4 weeks prior to study initiation or anticipated need for major surgery during the study.
7. Prior radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or major surgery for breast cancer.
8. Known hypersensitivity to any component of the study drugs.
9. Poorly controlled cardiac disease (e.g., NYHA class II+ heart failure, unstable angina, myocardial infarction within the past year, or clinically significant arrhythmias requiring intervention).
10. History of interstitial lung disease (ILD), current ILD, or suspected ILD on imaging during screening.
11. Active infections, including:

    * HIV positive
    * Active tuberculosis
    * Active hepatitis B (HBV-DNA \> 10\^3 IU/mL)
    * Active hepatitis C (HCV antibody positive with detectable HCV-RNA)
12. Active autoimmune disease requiring systemic treatment.
13. Dementia, significant intellectual impairment, or any psychiatric condition that impairs understanding of the informed consent.
14. Unhealed wounds, ulcers, or fractures within 4 weeks prior to signing consent; or any history of clinically significant bleeding or bleeding tendency.
15. Any other condition deemed by the investigator to be unsuitable for trial participation.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.