Combining serplulimab with chemotherapy for early HR+/HER2- breast cancer
Phase II Study Serplulimab Combined With Neoadjuvant Chemotherapy for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Breast Cancer
This study is testing if adding a new drug called serplulimab to standard chemotherapy can help people with early-stage HR+/HER2- breast cancer have better treatment outcomes before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 109 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | chemotherapy, immunotherapy, serplulimab, Pembrolizumab, Nivolumab |
| Locations | 1 site (Henan, Henan) |
| Trial ID | NCT06394661 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of serplulimab when combined with neoadjuvant chemotherapy in patients with early-stage HR+/HER2- breast cancer. Participants will receive serplulimab along with nab-paclitaxel and epirubicin every three weeks for six cycles, followed by surgery. The primary endpoint is to assess the rate of pathological complete response (pCR) at the time of definitive surgery. The study also seeks to identify any medical problems participants may experience while receiving serplulimab.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clinically measurable HR+/HER2- invasive breast cancer.
Not a fit: Patients with HER2-positive breast cancer or those with significant comorbidities affecting organ function may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the pCR rates in patients with early HR+/HER2- breast cancer.
How similar studies have performed: Previous studies have shown promising results with similar immunotherapy approaches in breast cancer, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Patients must meet all of the following criteria to be eligible: Age: ≥18 years old. Clinical-pathological confirmation: cT2-cT4 breast cancer, or cT1c with axillary lymph node metastasis. Histopathologically confirmed HR+/HER2- invasive breast cancer: ER and/or PR positive (IHC nuclear staining ≥1%). HER2-negative (IHC 0 or 1+ without FISH testing, or IHC 2+ with FISH-negative amplification). Ki67 ≥20%. Clinically measurable lesions: Measurable lesions confirmed by ultrasound, mammography, or MRI (optional) within 1 month prior to randomization. Adequate organ and bone marrow function (within 1 month prior to chemotherapy): Absolute neutrophil count (ANC) ≥2.0 × 10\^9/L. Hemoglobin ≥90 g/L. Platelet count ≥100 × 10\^9/L. Total bilirubin \<1.5 × ULN (upper limit of normal). Creatinine \<1.5 × ULN. AST/ALT \<1.5 × ULN. Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% by echocardiography. Reproductive status: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization. ECOG performance status: ≤1. Informed consent: Signed written informed consent. Exclusion Criteria Patients meeting any of the following criteria will be excluded: Evidence of metastatic breast cancer: Prior systemic therapy: Chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer. Second primary malignancy, except: Adequately treated non-melanoma skin cancer. Prior immunotherapy: Treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors. Immune-related conditions: Diagnosed immunodeficiency or active autoimmune disease. Severe cardiopulmonary disease: Uncontrolled or clinically significant. Active hepatitis B or C. Pregnancy or lactation: Pregnant or breastfeeding women. Other contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.
Where this trial is running
Henan, Henan
- Henan cacer hospital — Henan, Henan, China (Recruiting)
Study contacts
- Principal investigator: Zhenzhen Liu, PhD — Henan Cancer Hospital
- Study coordinator: Zhenzhen Liu
- Email: zlyyliuzhenzhen0800@zzu.edu.cn
- Phone: 13603862755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.