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RecruitingNCT07394387Updated May 15, 2026

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

A Phase 2 interventional study of Sintilimab and Abraxane in Triple Negative Breast Cancer (TNBC), sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Jan 2025, registered Nov 2025).
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

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.

02

Conditions studied

  • Triple Negative Breast Cancer (TNBC)
03

In context

Triple Negative Breast Neoplasms

1,139 studies on the registry are indexed under Triple Negative Breast Neoplasms; 442 are open to participants now.

This study's planned enrollment of 58 is close to the median of 61 across 981 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Cohort A (HIFU + Chemo + PD-1 Inhibitor)

    Drug: Sintilimab · Drug: Abraxane · Drug: Carboplatin · Procedure: High-intensity focused ultrasound (HIFU)

  • Experimental
    Cohort B (HIFU + PD-1 Inhibitor → Chemo + PD-1 Inhibitor)

    Drug: Sintilimab · Drug: Abraxane · Drug: Carboplatin · Procedure: High-intensity focused ultrasound (HIFU)

Interventions

  • DrugSintilimab

    200 mg, administered intravenously every 3 weeks.

  • DrugAbraxane

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

  • DrugCarboplatin

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

  • ProcedureHigh-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.

06

What researchers measure

Primary outcomes

  1. Pathologic Complete Response (pCR) Rate

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Proportion of participants with a ≥2-fold increase in CD8+ T cell count or IFN-γ level

    Time frame: 2 weeks after HIFU treatment (and concurrent PD-1 inhibitor for Cohort B), which is immediately prior to the start of the first cycle of neoadjuvant chemotherapy.

  2. Objective Response Rate (ORR)

    Time frame: Every 6 weeks during neoadjuvant therapy (at the end of cycles 2, 4, 6), up to up to 24 weeks

  3. Event-Free Survival (EFS)

    Time frame: From enrollment until the first occurrence of an event, assessed up to 5 years.

  4. Breast-Conserving Surgery (BCS) Rate

    Time frame: through study completion, an average of 1 year

  5. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    Time frame: Baseline, 1 month post-intervention, 6 months post-intervention and at study completion (an average of 1 year)

Other outcomes

  1. Overall Survival (OS)

    Time frame: From enrollment until death, assessed up to 5 years.

  2. predictive biomarkers for treatment efficacy

    Time frame: Biomarker samples are collected at baseline (pre-treatment) and at surgery (post-neoadjuvant therapy). Analysis will be performed after completion of patient enrollment and follow-up, through study completion, an average of 1 year.

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu, China
    Recruiting
08

References and documents

Publications

  • Bianchini G, De Angelis C, Licata L, Gianni L. Treatment landscape of triple-negative breast cancer - expanded options, evolving needs. Nat Rev Clin Oncol. 2022 Feb;19(2):91-113. doi: 10.1038/s41571-021-00565-2. Epub 2021 Nov 9. PubMed 34754128 ↗
  • Hu Z, Yang XY, Liu Y, Morse MA, Lyerly HK, Clay TM, Zhong P. Release of endogenous danger signals from HIFU-treated tumor cells and their stimulatory effects on APCs. Biochem Biophys Res Commun. 2005 Sep 16;335(1):124-31. doi: 10.1016/j.bbrc.2005.07.071. PubMed 16055092 ↗
  • Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8. PubMed 26869049 ↗
  • Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549. PubMed 32101663 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07394387
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
Jan 1, 2025
Primary completion
Jun 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
May 15, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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