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

Phase 2

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide

• Registration Number: NCT06500208
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Study Start: 2024-11-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adebrelimab and chemotherapy	Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide	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.

Primary Outcome Measures

Name	Time	Method
pCR rate	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 Outcome Measures

Name	Time	Method
Incidence of adverse events (Safety)	up to 8 months, after patients complete surgery	adverse events of patients receiving at least one cycle of treatment
ORR	up to 8 months, after patients complete surgery	Objective Response Rate: patients achieving partial response and complete response during treatment
pCR rate in PD-L1 CPS≥1 subgroup	up to 8 months, after patients complete surgery	pathological complete response rate in patients with PD-L1 CPS score ≥1