Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus 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.

Neoadjuvant Study of HIFU With or Without PD-1 Inhibitors Followed by Abraxane Plus Carboplatin in Triple-Negative Breast Cancer. (NCT07394387) is a Phase 2 interventional studying Triple Negative Breast Cancer (TNBC), sponsored by The First Affiliated Hospital with Nanjing Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Triple Negative Breast Cancer (TNBC) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 39 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Female patients aged ≥18 and ≤65 years. 2. diagnosed by tissue sample (biopsy-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. You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. 6. your organs (liver, kidneys, etc.) are working well enough based on blood tests, defined as: - blood count (hemoglobin) at least 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07394387), the sponsor (The First Affiliated Hospital with Nanjing Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07394387 clinical trial studying?

Who can participate in NCT07394387?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07394387?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07394387. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07394387. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.