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

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

This Phase 2 study will test whether adding serplulimab to nab-paclitaxel and epirubicin before surgery helps shrink early-stage HR+/HER2- breast cancers in adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 357 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, immunotherapy, Serplulimab
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06860529 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with cT2–cT4 or cT1c node-positive, ER/PR-positive, HER2-negative invasive breast cancer with Ki-67 ≥20% and adequate organ and cardiac function are the intended candidates.

Not a fit: Patients with HER2-positive tumors, low-proliferation cancers (Ki-67 <20%), poor organ or cardiac function, pregnancy, or who cannot attend the single study site are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the regimen could increase tumor shrinkage before surgery and potentially reduce recurrence risk for patients with HR+/HER2- disease.

How similar studies have performed: Immune checkpoint inhibitors plus chemotherapy have shown benefit in triple-negative breast cancer, but combining PD-1 inhibitors with chemo in HR+/HER2- neoadjuvant settings is relatively novel and not yet proven.

Eligibility criteria

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 this trial is running

Zhengzhou, Henan

• Henan cancer hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Zhenzhen Liu, Dr.

Conditions HR+/HER2- Breast Cancer