Actively Recruiting
NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
Led by Henan Cancer Hospital · Updated on 2025-06-23
709
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). The main questions it aims to answer are: Does serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature. Participants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the begining of the treatment.
CONDITIONS
Official Title
NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical tumor stage cT2 to cT4d, or cT1c with confirmed axillary lymph node metastasis
- Pathologically confirmed HR+/HER2- breast cancer defined as estrogen receptor or progesterone receptor positive (IHC nuclear staining >1%) and HER2 negative (IHC 0 or 1+ without FISH, or IHC 2+ with no amplification by FISH)
- Clinically measurable lesions on ultrasound, mammography, or optional MRI within 1 month before randomization
- Organ and bone marrow function tests within 1 month before chemotherapy show no contraindications
- Cardiac ultrasound ejection fraction (EF) value of 55% or higher
- Females of childbearing potential must have a negative serum pregnancy test within 14 days before randomization
- Eastern Cooperative Oncology Group (ECOG) performance status score of 1 or less
- Signed informed consent
You will not qualify if you...
- Evidence of metastatic breast cancer
- Prior chemotherapy, endocrine therapy, targeted therapy, or radiation therapy for this breast cancer
- Presence of a second primary cancer except for adequately treated skin cancer
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs, or other immunotherapy
- Diagnosis of immunodeficiency or autoimmune disease
- Severe lung or heart disease
- Active hepatitis B or C infection
- History of organ or bone marrow transplantation
- Pregnant or breastfeeding women
- Serious uncontrolled medical conditions that contraindicate chemotherapy as determined by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henan cancer hospital
Zhengzhou, China
Actively Recruiting
Research Team
Z
Zhenzhen Liu, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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