Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
Recruiting · NCT06964906 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab and chemotherapy as neoadjuvant therapy for ER+/HER2- breast cancer.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Female patients aged 18-75 years.
- Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3.
- Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Exclusion criteria
- Female patients during pregnancy or lactation.
- Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
- Has an active autoimmune disease that has received systemic treatment in the last 2 years.
- Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
- Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.
Where it is running
1 location listed.
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University - Hangzhou, Zhejiang, China