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Trial Title:
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in ER Positive/HER2 Low Breast Cancer
NCT ID:
NCT06340230
Condition:
ER Positive/HER2 Low Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
SHR-A1811
Adebrelimab
ER Positive/HER2 Low Breast Cancer
Neoadjuvant
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811 Injection + Adebrelimab Injection
Description:
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Arm group label:
Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection
Intervention type:
Drug
Intervention name:
SHR-A1811 Injection + Adebrelimab Injection
Description:
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Arm group label:
Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection
Intervention type:
Drug
Intervention name:
SHR-A1811 Injection
Description:
Drug: SHR-A1811 Injection
Arm group label:
Arm 3 SHR-A1811 Injection
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 ER 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients aged ≥ 18 but ≤ 75 years
2. Histologically confirmed to be ER+/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
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shengjing Hospital affiliated to China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Contact:
Last name:
Nan Niu, MD
Phone:
+8618940256668
Email:
niunannancy@163.com
Investigator:
Last name:
Caigang Liu, MD
Email:
Principal Investigator
Start date:
August 23, 2024
Completion date:
February 28, 2031
Lead sponsor:
Agency:
Shengjing Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06340230
