Actively Recruiting
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Led by Shengjing Hospital · Updated on 2024-12-04
93
Participants Needed
1
Research Sites
340 weeks
Total Duration
On this page
Sponsors
S
Shengjing Hospital
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 218 but 275 years
- Histologically confirmed HR+/HER2-Low invasive breast cancer
- Treatment-naive patients with stage II-III
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1
- Good level of organ function
- Voluntary participation, signed informed consent, good compliance, and cooperation with follow-up visits
You will not qualify if you...
- Previous anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, endocrine therapy, etc.)
- Concurrent anti-tumor therapy
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer
- Stage IV breast cancer
- Not confirmed by histopathology
- History of malignancies in past 5 years except cured cervical carcinoma in situ and melanoma skin cancer
- Participation in other drug clinical trials within 4 weeks before enrollment
- Known allergy to study drug components
- History of immunodeficiency
- Clinically significant cardiovascular diseases
- Known or suspected interstitial lung disease
- Active hepatitis or liver cirrhosis
- Known hereditary or acquired bleeding or thrombotic tendency
- History of neurological or psychiatric disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
Research Team
N
Nan Niu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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