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

NCT06500208 | Recruiting Phase 2

• 1 other identifier: RJBC-2402
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; ER+/HER2-; neoadjuvant; Adebrelimab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ORR

  up to 8 months, after patients complete surgery

• Incidence of adverse events (Safety)

  up to 8 months, after patients complete surgery

• pCR rate in PD-L1 CPS≥1 subgroup

  up to 8 months, after patients complete surgery

Study Arms (1)

Adebrelimab and chemotherapy

EXPERIMENTAL

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

Interventions

Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide DRUG

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

Adebrelimab and chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Haoyu Wang

CONTACT

86 021-64370045; meredithwhy@163.com

Xiaosong Chen

CONTACT

86 021-64370045; chenxiaosong0156@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 15, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)