Status:
UNKNOWN
Inetetamab Combined With Anti-PD-1 Monoclonal Antibody and Albumin-Bound Paclitaxel for HER2+ Metastatic Breast Cancer
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included...
Detailed Description
This is a multi-center, prospective, interventional, single-arm clinical trial. In the study, patients with her2-positive recurrent or metastatic breast cancer who were initially treated were included...
Eligibility Criteria
Inclusion
- Female patients aged \> 18 years.
- Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or ICH++ with fluorescence in situ hybridization results were positive).
- Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent or radiological evidence of metastatic disease.
- Patients with locally recurrent inoperable or metastatic HER2-positive breast cancer:
- patients with metastatic breast cancer at the time of initial diagnosis, meaning there was no previous history of breast cancer in the past; or
- patients with Locally recurrent or metastatic breast cancer, neoadjuvant/adjuvant anti-HER2 therapy has been completed for ≥6 months.
- HER2-positive recurrent or metastatic BC patients who have received at most one anti-HER2 therapy after diagnosis;.
- PD-L1-positive (cut-off ≥ 1% stained cells);
- Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria.
- ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up.
- Cardiopulmonary function is basically normal.
- Liver function is basically normal.
- Have sufficient baseline hematology parameters.
- Coagulation Indicators: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal, unless drugs known to change INR and aPTT are used.
- No history of serious heart, kidney and other important organs and endocrine disease.
- Female patients of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures.
- The patients voluntarily signed an informed consent form.
Exclusion
- Participated in other clinical trials within 4 weeks;
- Evidence of symptomatic central nervous system metastasis or pia mater disease.
- History of receiving CD137 agonists or checkpoint blockade therapy (including anti-CD40, anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody therapy).
- History of receiving paclitaxel for injection (Albumin Bound) in first-line chemotherapy for advanced disease.
- History of autoimmune disease Including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (IBD), etc.
- Immunosuppressive drugs required within 2 weeks before enrollment or during this study. The following conditions are excluded: 1) intranasal, inhalation, topical or local steroid injection (e.g., intra articular injection); 2) physiological doses of systemic corticosteroids (≤ 10 mg/day prednisone or equivalent dose); 3) short term (≤ 7 days) use of steroids to prevent or treat non-autoimmune allergic diseases.
- History of acute or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV).
- History of primary or acquired immunodeficiency (including HIV-positive).
- History of hypersensitivity to the study medication
- Pregnancy or lactation.
- History of myocardial infarction within 6 months before enrollment, congestive heart failure (New York Heart Association \[NYHA\] Classes ≥ II), severe arrhythmia beyond drug control, or a decrease in LVEF to \< 50% with previous trastuzumab neoadjuvant or adjuvant treatment.
- History of other malignant disease within 5 years (except cured of in-situ carcinoma of the cervix, basal cell carcinoma of the skin and squamous cell carcinoma).
- Participants who were judged by the investigator to be unsuitable for this study .
Key Trial Info
Start Date :
March 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05291910
Start Date
March 12 2022
End Date
December 31 2025
Last Update
March 23 2022
Active Locations (1)
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1
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, China