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Trial Title:
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer
NCT ID:
NCT06331169
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Trastuzumab deruxtecan
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Anlotinib
Description:
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular
endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR),
platelet-derived growth factor receptors (PDGFR), and c-kit.
Arm group label:
Anlotinib dose escalation + trastuzumab deruxtecan
Other name:
Anlotinib dihydrochloride
Intervention type:
Drug
Intervention name:
Trastuzumab deruxtecan
Description:
Trastuzumab deruxtecan is an antibody-drug conjugate composed of an anti-HER2 (human
epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and
a cytotoxic topoisomerase I inhibitor.
Arm group label:
Anlotinib dose escalation + trastuzumab deruxtecan
Other name:
DS-8201
Summary:
This study will evaluate the safety, tolerability and efficacy of anlotinib and
trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low
unresectable and/or metastatic breast cancer who had received ≤1 line of prior
chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer
that:
1. Is unresectable or metastatic.
2. Has a history of low HER2 expression (IHC 1+& IHC 2+/ISH- or 0
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jian Zhang
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Jian Zhang, MD,PhD
Phone:
+8664175590
Phone ext:
85000
Email:
syner2000@163.com
Start date:
July 31, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06331169
