Actively Recruiting
SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-05-17
20
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer
CONDITIONS
Official Title
SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Female with ER/PgR expression 10% or less and low HER2 expression (IHC 1+, or IHC 2+ and ISH-)
- Advanced breast cancer patients
- Prior treatment with at least one line of therapy for localized recurrence or metastatic disease
- Received taxane or anthracycline therapy at least once
- Allowed to have received immunotherapy during neoadjuvant or adjuvant stages
- Measurable lesions according to RECIST 1.1 standards
- ECOG performance status score of 0 or 1
- Voluntary participation with good compliance
- Negative pregnancy test for childbearing-age participants and commitment to effective contraception from study start to 6 months after last dose
- Adequate organ function including specified blood counts, liver and kidney function, coagulation parameters, and left ventricular ejection fraction of 50% or higher
- Stable liver function for at least 1 week after routine liver protection treatment as assessed by investigator
You will not qualify if you...
- Active central nervous system metastases or carcinomatous meningitis (stable brain metastases allowed)
- Prior treatment with anti-HER2 antibody-drug conjugates
- Active or history of autoimmune disease requiring immunosuppressive therapy
- Use of immunosuppressants or systemic steroids (>10mg/day prednisone or equivalent) within 2 weeks before inclusion
- History or presence of other malignant tumors
- Grade 4 adverse reactions after ADC drug treatment or grade 3 immune-related adverse reactions
- Known allergy to study drug components
- Known interstitial pneumonia
- Poorly controlled heart conditions including NYHA class 2 or above heart failure, unstable angina, myocardial infarction within past year, or significant arrhythmias
- Active infection or unexplained fever above 38.5°C during screening or before first dose
- Receipt of live vaccines within 4 weeks before or during study
- History of psychiatric drug abuse, alcoholism, or drug addiction
- Other serious diseases or conditions affecting safety or study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, China, 00
Actively Recruiting
Research Team
Q
Qiao Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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