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

A Single-Center, Phase II Clinical Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin Neoadjuvant Therapy in Triple-Negative Breast Cancer.

This study will try focused ultrasound (HIFU) with or without the immune drug sintilimab before standard chemotherapy to see if people with early-stage triple‑negative breast cancer can achieve a complete tumor response.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: chemotherapy, immunotherapy, Sintilimab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07394387 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–65 with histologically confirmed stage II–III triple‑negative breast cancer, at least one measurable lesion, ECOG 0–1, and adequate organ, cardiac, and thyroid function who have not received prior breast cancer therapy are ideal candidates.

Not a fit: Patients with metastatic disease, other breast cancer subtypes, prior systemic or local breast cancer treatment, or significant cardiac, thyroid, or organ dysfunction are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the approach could increase the chance of a pathological complete response before surgery and potentially improve longer‑term outcomes for patients with early TNBC.

How similar studies have performed: Neoadjuvant PD‑1 inhibitors plus chemotherapy have raised pCR rates in other TNBC trials (for example pembrolizumab), but combining HIFU with immunotherapy remains an early and less‑tested strategy.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged ≥18 and ≤65 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 this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Conditions: Triple Negative Breast Cancer