Combining Serplulimab with Chemotherapy for Early-stage HR+/HER2- Breast Cancer

Neoadjuvant NabPE With or Without Serplulimab for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Breast cancer-an Observational Real-world Study.

This study is testing if adding a new drug called serplulimab to standard chemotherapy helps people with early-stage HR+/HER2- breast cancer have better outcomes before surgery.

Quick facts

• Study type: Observational
• Enrollment: 709 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, serplulimab, Pembrolizumab, nivolizumab
• Locations: 1 site (Zhengzhou)
• Trial ID: NCT06781281 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effectiveness of serplulimab in combination with neoadjuvant chemotherapy for 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 pathological complete response (pCR) rate at the time of definitive surgery, comparing results to existing literature on chemotherapy alone. The study also seeks to identify any medical issues participants may experience while receiving serplulimab.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed HR+/HER2- breast cancer and measurable lesions.

Not a fit: Patients with metastatic breast cancer or those who have previously received treatment for this disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with early-stage HR+/HER2- breast cancer by increasing the pCR rate.

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

Inclusion Criteria:

1. Age\>=18 years old
2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
3. Pathologically proven HR+/HER2- breast cancer:

   defined as:
   * positive for ER or PR (IHC nuclear staining \>1%)
   * Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
6. Cardiac ultrasound EF value ≧55%；
7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
8. ECOG score≤1 point;
9. Sign informed consent；

Exclusion Criteria:

1. The patient has evidence of metastatic breast cancer；
2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
3. The patient has a second primary malignancy other than adequately treated skin cancer;
4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
6. The patient has severe lung or heart disease;
7. The patient has active hepatitis B and C;
8. The patient has a history of organ transplantation or bone marrow transplantation;
9. pregnant or breastfeeding women;
10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.

Where this trial is running

Zhengzhou

• Henan cancer hospital — Zhengzhou, China (Recruiting)

Study contacts

• Study coordinator: Zhenzhen Liu, Dr.

Conditions Breast Cancer Invasive; HR+/HER2-; PD1; Real-world study