Clinical trial · Interventional
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low 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)
This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
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 |
|---|---|---|---|
| HR Positive/HER2 Low Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-A1811 Injection | Drug | — | UNRESOLVED |
| SHR-A1811 Injection + Adebrelimab Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection
- description
- SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
- interventionNames
- Drug: SHR-A1811 Injection + Adebrelimab Injection
- type
- EXPERIMENTAL
- label
- Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection
- description
- SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
- interventionNames
- Drug: SHR-A1811 Injection + Adebrelimab Injection
- type
- EXPERIMENTAL
- label
- Arm 3 SHR-A1811 Injection
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged ≥ 18 but ≤ 75 years 2. Histologically confirmed to be HR+/HER2-Low invasive breast cancer 3. Treatment-naive patients with stage II-III 4. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 5. Good level of organ function 6. Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits Exclusion Criteria: 1. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. Received any other anti-tumor therapy at the same time 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer 4. Stage IV breast cancer 5. Not confirmed by histopathology 6. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer 7. Participated in other drug clinical trials within 4 weeks before enrollment 8. Known allergic history of the drug components of this protocol 9. History of immunodeficiency 10. Clinically significant cardiovascular diseases 11. Known or suspected interstitial lung disease 12. Active hepatitis and liver cirrhosis 13. Known hereditary or acquired bleeding thrombotic tendency 14. History of neurological or psychiatric disorders
References
Publications (0)
Data not yet available