Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC

Official title

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

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.

Interventions

• Drug Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
  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

Primary outcome measures

• pCR rate [Time frame: up to 8 months, after patients complete surgery]

Secondary outcome measures (3)

• ORR [Time frame: up to 8 months, after patients complete surgery]
• Incidence of adverse events (Safety) [Time frame: up to 8 months, after patients complete surgery]
• pCR rate in PD-L1 CPS≥1 subgroup [Time frame: up to 8 months, after patients complete surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Ruijin Hospital — Shanghai

Identifiers

NCT: NCT06500208 · RJBC-2402

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗