This is a phase 2, open-label, multicenter study to evaluate the efficacy and tolerability
of poziotinib in approximately 70 patients with HER2-positive metastatic breast cancer who
have received at least 2 prior HER2-directed treatment regimens.
Each treatment cycle will be 21 days in duration. During each 21-day cycle, patients who are
eligible for participation will receive poziotinib orally once daily for 14 days, followed
by 7 treatment-free rest days.
All treated patients will be followed up until disease progression, death, intolerable
adverse events or up to a maximum of 24 months whichever comes earlier.
1. Histopathologically confirmed metastatic breast cancer
2. Confirmed HER2 overexpression or gene-amplified tumor
3. At least 2 prior HER2-directed therapy regimens for metastatic breast cancer,
including trastuzumab and TDM-1.
4. Patient is at least 18 years of age.
5. Patient has adequate hematologic, hepatic, and renal functions
6. At least one measurable lesion
1. Previous treatment with poziotinib prior to study participation.
2. Brain metastases that are untreated, symptomatic, or require therapy to control
symptoms, as well as any history of radiation, surgery, or other therapy, including
steroids, to control symptoms from brain metastases within 1 month (30 days) of
3. Anticancer chemotherapy, biologics, immunotherapy, radiotherapy, or investigational
treatment within 30 days, except for hormone therapy, which could be given up to 7
days prior to the first dose of poziotinib.
4. History of congestive heart failure (CHF) Class III/IV according to the New York
Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias
5. Patient has a cardiac ejection fraction <50%
6. Patient has a history of other malignancies within the last 5 years
7. Unable to take drugs orally
8. Patient is pregnant or breast-feeding.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Adverse Events experience by participants as a measure of toxicity
Progression Free Survival (PFS)
Disease Control Rate (DCR)
Overall Survival (OS)
Time to Progression (TTP)