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Trial Title:
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
NCT ID:
NCT06500208
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Cyclophosphamide
Epirubicin
Conditions: Keywords:
breast cancer
ER+/HER2-
neoadjuvant
Adebrelimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
Description:
Adebrelimab 1200mg i.v. q3w combined with nab-paclitaxel 100mg/m2 qw*12w followed by
epirubicin 90mg/m2 and cyclophosphamide 600mg/m2 q3w for 4 cycles
Arm group label:
Adebrelimab and chemotherapy
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
November 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500208
