Can an immunotherapy combo boost tumor shrinkage in a common breast cancer?
NCT ID NCT06860529
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This trial is testing whether adding the immunotherapy drug serplulimab to standard chemotherapy (albumin paclitaxel and epirubicin) before surgery can improve outcomes for people with early-stage HR+/HER2- breast cancer. The study focuses on how well the combination shrinks tumors, especially in those with a biomarker called PD-L1. It also monitors side effects and long-term outcomes like disease-free survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Serplulimab (an immunotherapy drug) combined with chemotherapy (albumin paclitaxel and epirubicin)
- What this could lead to
- If it works, this combination could become a new neoadjuvant option to shrink tumors before surgery and potentially improve long-term outcomes in HR+/HER2- breast cancer.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. Adding immunotherapy may increase immune-related side effects, and the benefit over standard chemotherapy is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 357 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan cancer hospital
RECRUITINGZhengzhou, Henan, 450000, China
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