An Open-label, One-arm Phase II Study of Adebrelimab Combined With Neoadjuvant Chemotherapy for High-risk, Early-stage and Locally Advanced Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer.
Overview
- Phase
- Phase 2
- Intervention
- Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
- Conditions
- Breast Cancer
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- pCR rate
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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 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.
Investigators
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine
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;
Arms & Interventions
Adebrelimab and chemotherapy
Adebrelimab 1200 mg Q3W combined with nab-paclitaxel (100 mg/m2 Q1W) for 4 cycles followed by epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) Q3W for 4 cycles.
Intervention: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
Outcomes
Primary Outcomes
pCR rate
Time Frame: up to 8 months, after patients complete surgery
pathological complete response rate: No invasive residual disease in surgical specimen of breast and axillary lymph nodes
Secondary Outcomes
- Incidence of adverse events (Safety)(up to 8 months, after patients complete surgery)
- ORR(up to 8 months, after patients complete surgery)
- pCR rate in PD-L1 CPS≥1 subgroup(up to 8 months, after patients complete surgery)