Actively Recruiting
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2025-06-26
48
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of immune checkpoint inhibitors to traditional neoadjuvant chemotherapy can improve the pathologic complete response rate (pCR) of patients, evaluate its therapeutic safety, and further analyze the biomarkers of the efficacy of neoadjuvant immunotherapy for ER+/HER2- breast cancer, so as to support the clinical application of the drug.
CONDITIONS
Official Title
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically diagnosed unilateral primary invasive breast cancer with cT1c-T2N1-3 or cT3-4N0-3, and Tumor Grade 3 or Grade 2 with PR- or Ki67 > 20%
- IHC ER expression 651%; IHC HER2 0 or 1+, or IHC HER2 2+ with no amplification in FISH test
- At least one measurable lesion per RECIST 1.1
- Available core needle biopsy samples for PD-L1 testing
- ECOG performance status 0 or 1 within 10 days before treatment start
- Not pregnant or breastfeeding and agree to strict contraception during treatment and at least 6 months after last dose
- Normal hematologic, liver, renal and heart functions
- Signed written informed consent
You will not qualify if you...
- Bilateral invasive breast cancer or Stage IV breast cancer
- Severe heart disease
- Immune deficiency or systemic steroid/immunosuppressive therapy within 7 days before first treatment dose
- Active autoimmune diseases requiring systemic therapy in past 2 years
- Severe systemic infections or serious medical conditions
- Other cancers in past 5 years except cured cervical carcinoma in situ and non-melanoma skin cancer
- History of HIV infection
- Active hepatitis B or C infection
- Known allergies or intolerance to study drug or its excipients
- Previous immunotherapy targeting PD-1/PD-L1/T cell receptors
- Investigator judged unsuitable for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
H
Haoyu Wang
CONTACT
X
Xiaosong Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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