Status:
RECRUITING
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
Brief Summary
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 explor...
Eligibility Criteria
Inclusion
- pathologically diagnosed as unilateral primary invasive breast cancer with a) cT1c-T2N1-3 or cT3-4N0-3, b) Tumor Grade 3 or Grade 2 with PR- or Ki67 \> 20%;
- IHC ER expression ≥1%; IHC HER2 0 or 1+; IHC HER2 2+ and no amplification in FISH test;
- At least one measurable lesion according to RECIST 1.1;
- Available core needle biopsy samples for PD-L1 status testing;
- ECOG 0 or 1 within 10 days prior to initiation of treatment;
- Not currently pregnant or breastfeeding, agree to strict contraception during treatment and at least 6 months after last dose;
- Intact hematologic, liver, renal and heart functions;
- Signed written informed consent.
Exclusion
- Bilateral invasive breast cancer or Stage IV breast cancer;
- Severe heart disease;
- Diagnosed as immune deficiency or receiving systemic steroid therapy or any form of immuno-suppressive therapy within 7 days prior to the first dose of treatment;
- Had active autoimmune diseases requiring systemic therapy within the past 2 years;
- Severe systemic infections or other serious medical conditions;
- Other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix and skin cancer without melanoma;
- History of HIV infection;
- Active HBV or HCV infection;
- Known allergies or intolerance to the therapeutic drug or its excipients;
- History of application of any immunotherapy targeting PD-1/PD-L1/T cell receptors;
- Judged by the investigator to be unsuitable to participate in this study.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06500208
Start Date
November 1 2024
End Date
December 31 2026
Last Update
June 26 2025
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025