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

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

Trial Details

NCT ID
NCT07394387
Phase
PHASE2
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Sintilimab
  • Abraxane
  • Carboplatin
  • High-intensity focused ultrasound (HIFU)
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • Female patients aged ≥18 and ≤70 years.
  • Histologically confirmed invasive breast cancer, classified as Stage II-III triple-negative breast cancer (TNBC) according to the 8th edition AJCC …
  • At least one measurable lesion as per RECIST v1.1 criteria.
  • No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.

For full eligibility, visit ClinicalTrials.gov.

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