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.
You may not be if
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.
Clareo Health | Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
