Combining high-intensity focused ultrasound with immunotherapy and chemotherapy for breast cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of high-intensity focused ultrasound (HIFU) combined with toripalimab and chemotherapy compared to chemotherapy alone as neoadjuvant therapy for patients with ER+/HER2- breast cancer. Participants will be randomly assigned to either receive the experimental treatment or standard chemotherapy over 8 cycles, each lasting 21 days. Following the treatment, all participants will undergo surgery within 6 weeks to assess the outcomes of the therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female patients aged 18-75 years.
2. Invasive breast cancer without distant metastasis, including either T1c-T4 (≥ 2 cm), cN0-cN3.
3. Histopathologically confirmed ER-positive/HER2-negative, PR \< 20% or Ki67 ≥ 20%, Grade 3 breast cancer.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Exclusion Criteria:

1. Female patients during pregnancy or lactation.
2. Diagnosis of bilateral breast cancer, occult breast cancer, or distant metastasis confirmed by pathology.
3. Has an active autoimmune disease that has received systemic treatment in the last 2 years.
4. Has a known history of human immunodeficiency virus (HIV), hepatitis B, or known active hepatitis C virus infection.
5. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
6. Has a known history of invasive malignancy that required systemic treatment in the last 5 years.
7. Uncontrolled concomitant diseases include severe infection, liver disease, cardiovascular disease, kidney disease, respiratory disease, diabetes, and others requiring systemic treatment.

Where it's running

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Yiding Chen — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Yiding Chen
• Email: ydchen@zju.edu.cn
• Phone: +86 0571 87783759

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Propranolol with Toripalimab and Platinum Chemo before/around surgery in NSCLC

  This study tests whether adding propranolol to toripalimab and platinum-based chemotherapy is safe and tolerable for people with resectable non-small cell lung cancer before surgery.

  Recruiting Phase 1 Second Xiangya Hospital of Central South University · Changsha, Hunan and 3 other locations · NCT07886229

• Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC

  This study tests whether using Cryo-Thermal Ablation before chemo-immunotherapy helps people with resectable NSCLC see better outcomes.

  Recruiting Phase 2 West China Hospital · Chengdu, Sichuan and 8 other locations · NCT07855965

• Rimegepant plus toripalimab in advanced urothelial cancer after standard therapy

  This small, early-stage study tests whether combining rimegepant with toripalimab is safe and shows signs of activity in adults with advanced urothelial cancer that did not respond to prior treatment.

  Recruiting at 2 sites Phase 1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality and 1 other locations · NCT07835035

• SABR with Axitinib and Toripalimab for oligometastatic kidney cancer

  This phase 2 trial tests whether giving SABR radiation together with axitinib and toripalimab can shrink tumors and help patients with up to five metastatic sites from clear cell renal cell carcinoma.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07744932

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.