Status:
UNKNOWN
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
HER2-targeted therapy after the failure of trastuzumab treatment has become a new difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line tr...
Detailed Description
Trastuzumab is the first target drug for HER2 positive metastatic breast cancer, which can significantly improve the survival of patients with HER2 positive metastatic breast cancer and become the fir...
Eligibility Criteria
Inclusion
- Subjects must meet all of the following conditions:
- Adult female patients (age 18-70 years) with metastatic breast cancer confirmed by pathology or imaging;
- Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive);
- Received trastuzumab treatment in the past;
- the patients have received 1-3 treatments for metastatic breast cancer in the past;
- According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;
- ECoG score of physical status was less than 2, and the expected survival time was not less than 3 months;
- Prior treatment-related toxicity should be reduced to NCI CTCAE (version 5.0) ≤ 1 degree (except for hair loss or other toxicity which is considered as no risk to patient's safety according to the investigator's judgment) 8）LVEF≥50%；
- 9\) Sufficient functional reserve of bone marrow
- White blood cell count (WBC) ≥ 3.0 × 10 \^ 9 / L,
- Neutrophil count (ANC) ≥ 1.5 × 10 \^ 9 / L,
- Platelet count (PLT) ≥ 100 × 10 \^ 9 / L 10) Previous treatment-related toxicity should be relieved as NCI CTCAE (version 5.0) ≤ 1 degree, total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; 11) Be able to understand the research process, volunteer to participate in the study, and sign informed consent.
Exclusion
- Subjects were not allowed to participate in the study if they had any of the following conditions:
- No trastuzumab treatment was received;
- Have received more than 3 therapeutic regimens for metastatic breast cancer;
- No treatment for metastatic breast cancer was received;
- Patients who are known to be allergic to active or other components of the study drug.
- They received radiotherapy, chemotherapy, endocrine therapy within 4 weeks before enrollment, or were participating in any clinical trials of intervention drugs;
- Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period.
- Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 9 2024
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04681911
Start Date
September 9 2020
End Date
September 9 2024
Last Update
December 23 2020
Active Locations (1)
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1
Sun Yat Sen Memorial Hospital，Sun Yat sen University
Guangzhou, Guangdong, China, 510000