Status:
UNKNOWN
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
HER2-positive Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive...
Eligibility Criteria
Inclusion
- Written informed consent
- Female subjects with age 18 to 70 (inclusive) years at the time of consent
- LVEF ≥50% at baseline
- ECOG performance status of 0-1
- Have not received 1L treatment for recurrent or metastatic breast cancer
- Adequate organ function
Exclusion
- History of exposure to the cumulative doses of doxorubicin \> 400 mg / m2 or equivalent
- History of autoimmune diseases
- Active brain metastasis
- Concurrent diseases that compromise patient's safety
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04034823
Start Date
September 1 2019
End Date
January 1 2022
Last Update
July 26 2019
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