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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Haoyu Wang; Phone Number: 86 021-64370045; Email: meredithwhy@163.com
• Study Contact Backup: Name: Xiaosong Chen; Phone Number: 86 021-64370045; Email: chenxiaosong0156@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Contact: Haoyu Wang; Phone Number: 86 021-64370045; Email: meredithwhy@163.com
      • Contact: Xiaosong Chen; Email: chenxiaosong0156@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR rate	pathological complete response rate: No invasive residual disease in surgical specimen of breast and axillary lymph nodes	up to 8 months, after patients complete surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 6, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; neoadjuvant; ER+/HER2-; Adebrelimab
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Antibiotics, Antineoplastic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Cyclophosphamide; Paclitaxel; Epirubicin
• Other Study ID Numbers: RJBC-2402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No