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

A Randomized, Open-Label, Blinded Endpoint Study of High-Intensity Focused Ultrasound (HIFU) Combined With Toripalimab Plus Chemotherapy Versus Chemotherapy as Neoadjuvant Therapy for Estrogen Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (NeoHunter)

This study is testing if combining high-intensity focused ultrasound with immunotherapy and chemotherapy can help women with a specific type of breast cancer more than just chemotherapy alone.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Drugs / interventions: toripalimab, chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06964906 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are female patients aged 18-75 with invasive ER+/HER2- breast cancer without distant metastasis.

Not a fit: Patients with active autoimmune diseases, prior anti-PD-1 therapy, or those with distant metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with ER+/HER2- breast cancer by enhancing the efficacy of neoadjuvant therapy.

How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged 18-75 years.
2. Invasive breast cancer without distant metastasis, including either T1c-T2 (≥ 2 cm), cN1-cN2, or T3-T4, cN0-cN2.
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 this trial is running

Hangzhou, Zhejiang

• 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

Conditions: ER+/HER2- Breast Cancer, Breast Neoplasms, High-intensity focused ultrasound, PD1, Toripalimab, nab-Paclitaxel, Epirubicin, Cyclophosphamide