Neoadjuvant treatment for lymph node-positive HR+ breast cancer

Neoadjuvant Toripalimab and Radiotherapy Treatment in Lymph Nodes Positive HR Positve Breast Cancer（NEOTRIO-HR）

This study is testing if combining a new immunotherapy drug with different types of radiation and chemotherapy can help people with lymph node-positive HR+ breast cancer respond better to treatment before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: prednisone, toripalimab, chemotherapy, radiation, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06671262 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of combining toripalimab, a type of immunotherapy, with radiotherapy and chemotherapy in patients with lymph node-positive HR+/HER2- breast cancer. Participants will be randomly assigned to one of three treatment regimens: intensified radiation targeting both the primary tumor and axillary lymph nodes, intensified radiation focused solely on the primary tumor, or toripalimab combined with chemotherapy alone. The study seeks to determine if the addition of intensified radiation can enhance the pathologic complete response (pCR) rate and improve the tumor immune microenvironment. Following treatment, participants will undergo surgery to assess the effectiveness of the therapies.

Who should consider this trial

Good fit: Ideal candidates include women with high-risk HR+/HER2-negative breast cancer who are lymph node-positive and have not shown distant metastasis.

Not a fit: Patients with HER2-positive breast cancer or those with distant metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with HR+/HER2- breast cancer.

How similar studies have performed: Previous studies have shown promising results with similar approaches combining immunotherapy and intensified radiation in breast cancer treatment.

Eligibility criteria

Inclusion Criteria:

* High-risk HR+/HER2-negative breast cancer is defined as ER≥1%, HER2-negative (\<2+ Her2 IHC or \<2.2 HER2/CEP17 ratio by FISH) and either histologic grade II-III or a high-risk genomic assay score (Oncotype RS\>25, high risk Mammaprint, PAM-50, EndoPredict or ProSigna score). primary tumor size ≥1.0 cm in maximum diameter and axillary node-positive breast cancer;
* Stage T1-4N+M0 (i.e., Stage II, III), with confirmed N+ by biopsy, and no signs of distant metastasis;
* The initial PD-L1 expression level conducted on the tumor tissue sample with Combined Positive Score (CPS) or Tumor Proportion Score (TPS)\< 10%;
* ECOG score of 0-1;
* Screening laboratory values must meet the following criteria: i. White blood cells (WBCs) ≥ 2000/μL ii. Absolute neutrophil count (ANC) ≥ 1500/μL iii. Platelets ≥ 100 x 103/μL iv. Hemoglobin ≥ 11.0 g/dL v. Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min) vi. AST ≤ 2.5 x upper limit of normal (ULN) vii. ALT ≤ 2.5 x ULN viii. Total bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL) ix. INR ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulant(s) x. Negative HIV screening test xi. Negative screening tests for Hepatitis B and Hepatitis C. Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.

Exclusion Criteria:

* Inflammatory breast cancer
* Life-threatening organ dysfunction or complications, active infectious diseases, active hepatitis B, hepatitis C virus infection, autoimmune diseases within two years, undergoing immunosuppressive drug treatment or chronic systemic corticosteroid therapy (dose exceeding 10mg per day of prednisone or equivalent);
* Clinically symptomatic heart disease;
* Previous systemic treatment or radiotherapy for breast cancer;
* Patients with cosmetic breast implants, i.e., having implants under the skin at the time of diagnosis;
* Radiotherapy contraindications: history of radiotherapy;
* Women shall not be breastfeeding.

Where this trial is running

Hangzhou, Zhejiang

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

Study contacts

• Study coordinator: Jian Huang

Conditions Breast Adenocarcinoma