The purpose of this study is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), in HER2-overexpressed recurrent stage IV breast cancer patients who received at least 2 prior HER2-directed regimens.
To evaluate the efficacy of NOV120101 (Poziotinib) as a therapeutic agent for HER2-overexpressed recurrent stage IV breast cancer, patients who have received at least two prior HER2-directed regimens will be enrolled in this study. Subjects will receive NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by 1-week drug-free intervals between cycles until disease progression or unacceptable toxicity development. Progression Free Survival (PFS) will be analyzed as the primary endpoint in this trial. Secondary endpoints including PFS rate at 12 weeks, ORR, DCR, OS and TTP will also be analyzed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
106
NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval between cycles until disease progression or unacceptable toxicity development
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Samsung Medical Center
Gangnam-gu, Seoul, South Korea
Progression free survival (PFS)
Time frame: By 12 months after enrollment of the last subject
PFS rate at Week 12
Time frame: 12 weeks
Objective Response Rate (ORR)
the proportion of patients with complete response (CR) and/or partial response (PR)
Time frame: By 12 months after enrollment of the last subject
Disease Control Rate (DCR)
the proportion of patients with CR, PR and/or stable disease (SD)\] \[Safety Issue?
Time frame: By 12 months after enrollment of the last subject
Duration of Disease Control
Time frame: By 12 months after enrollment of the last subject
Overall Survival (OS)
Time frame: By 12 months after enrollment of the last subject
Time To Progression (TTP)
Time frame: By 12 months after enrollment of the last subject
Time to objective response
Time frame: By 12 months after enrollment of the last subject
Duration of objective response
Time frame: By 12 months after enrollment of the last subject
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Seoul National University Hospital
Jongno-gu, Seoul, South Korea
Severance Hospital
Seodaemun-gu, Seoul, South Korea
Asan Medical Center
Songpa-gu, Seoul, South Korea