Neoadjuvant treatment for HR Positive/HER2 Low Breast Cancer using SHR-A1811 and Adebrelimab
A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
This study is testing a new treatment combination for people with Stage II-III HR Positive/HER2 Low Breast Cancer to see if it can help shrink tumors before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 93 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy, Adebrelimab |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06340230 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial evaluates the safety and efficacy of SHR-A1811 alone or in combination with Adebrelimab as neoadjuvant therapy for patients with Stage II-III HR Positive/HER2 Low Breast Cancer. Participants will receive the treatment for six cycles, followed by surgery within four weeks after the therapy. Efficacy will be monitored every two cycles to assess the response to the treatment. The study aims to provide insights into the potential benefits of this combination therapy in improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 75 with treatment-naive Stage II-III HR Positive/HER2 Low invasive breast cancer.
Not a fit: Patients with previous anti-tumor therapies or Stage IV breast cancer are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve surgical outcomes and overall survival rates for patients with HR Positive/HER2 Low Breast Cancer.
How similar studies have performed: Other studies have shown promise with similar neoadjuvant therapies, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shenyang, Liaoning
- Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Caigang Liu, MD — Shengjing Hospital
- Study coordinator: Nan Niu, MD
- Email: niunannancy@163.com
- Phone: 86-18940256668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.