Serplulimab plus nab-paclitaxel and epirubicin for early HR+/HER2- breast cancer

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 Phase 2, single-center neoadjuvant trial gives adults with HR+/HER2- invasive breast cancer a combination of serplulimab (a PD-1 inhibitor) with nab-paclitaxel and epirubicin prior to surgery. Eligible patients have cT2–cT4 disease or cT1c with axillary node involvement, are ER and/or PR positive, HER2 negative, and have Ki-67 ≥20% with measurable tumors and adequate organ function. The study will track tumor response, pathological response at surgery, and safety/tolerability of the combination. All treatments and assessments are conducted at Henan Cancer Hospital in Zhengzhou, China.

Why it matters

Who can join: the full rules

3.1 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.

3.2 Exclusion Criteria

Patients meeting any of the following criteria will be excluded:

Evidence of metastatic breast cancer:

Chest/abdominal CT and bone scan required at any time from diagnosis to randomization to exclude metastasis.

PET/CT may substitute for other imaging modalities.

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: Hepatitis B or C with detectable viral load.

Transplant history: Prior organ or bone marrow transplantation.

Pregnancy or lactation: Pregnant or breastfeeding women.

Other contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.

Where it's running

• Henan cancer hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Zhenzhen Liu, Dr.
• Email: liuzhenzhen73@126.com
• Phone: 13603862755

Similar studies

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

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• NeoCSR-Omics: CAPOX and Serplulimab Before or After Short-Course RT in Locally Advanced Rectal Cancer

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• YL201 plus serplulimab vs the usual chemo combo as first treatment for extensive-stage small cell lung cancer

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  Recruiting at 2 sites Phase 3 MediLink Therapeutics (Suzhou) Co., Ltd. · Guangzhou, Guangdong and 1 other locations · NCT07739758

• AI-powered pre-treatment MRI to predict chemotherapy response in HR+/HER2- breast cancer

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• Low-dose carboplatin with nab-paclitaxel plus delayed serplulimab as first-line therapy for advanced squamous NSCLC

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• HIPEC-primed therapy with serplulimab plus SOX/XELOX for locally advanced gastric cancer

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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.