Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adebrelimab and chemotherapy
- description
- 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.
- interventionNames
- Drug: Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
Primary outcomes (1)
- measure
- pCR rate
- timeFrame
- up to 8 months, after patients complete surgery
- description
- pathological complete response rate: No invasive residual disease in surgical specimen of breast and axillary lymph nodes
Secondary outcomes (3)
- measure
- ORR
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available