Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy f… (NCT06964906) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab and Chemotherapy for ER-Positive /HER2-Negative Breast Cancer
China30 participantsStarted 2025-03-04
Plain-language summary
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 participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0
Timeframe: Up to approximately 30 weeks
Trial details
NCT IDNCT06964906
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine