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Clinical Trials in China / NCT06340230
Recruiting Phase 2

SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

NCT06340230 · tracked via the Priya Life Science China tracker
Sponsor
Shengjing Hospital
Phase
Phase 2
Started
2024-08-23
Last updated
2024-12-04

Condition(s) studied

HR Positive/HER2 Low Breast Cancer

Investigational drug(s) / intervention(s)

SHR-A1811 Injection + Adebrelimab InjectionAll Trastuzumab Rezetecan trials (39) →All Adebrelimab trials (90) →SHR-A1811 Injection + Adebrelimab InjectionAll Trastuzumab Rezetecan trials (39) →All Adebrelimab trials (90) →SHR-A1811 Injection →

SHR-A1811 Injection + Adebrelimab Injection: Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

SHR-A1811 Injection + Adebrelimab Injection: Drug: SHR-A1811 Injection Drug: Adebrelimab Injection

SHR-A1811 Injection: Drug: SHR-A1811 Injection

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shengjing Hospital affiliated to China Medical University Shenyang Liaoning Recruiting

More Shengjing Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06340230 on ClinicalTrials.gov ↗ ← All trials in China