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New treatment option for HR+/HER2- Breast Cancer
Official title Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer
ClinicalTrials.gov ID: NCT06860529
What this study is testing
What is Serplulimab?
Serplulimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hr+/her2- breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The neoadjuvant treatment options commonly used for HR+/HER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 3.1 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:
You likely can't join if
- 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:
See the full eligibility criteria
- 3.1 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.