Clinical trial · Interventional
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
A Phase 2 Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC
NCT02659514CI-TRIAL-00057068completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Poziotinib | Drug | Poziotinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1: Poziotinib 24 mg
- description
- Participants received poziotinib 24 milligrams (mg), administered as three 8 mg tablets, orally, once daily (QD) on an intermittent dosing schedule of 14 days on treatment followed by 7 days off treatment, in a 21-day cycle until disease progression, death, intolerable adverse events (AEs) or for up to a maximum of 24 months, whichever occurs first.
- interventionNames
- Drug: Poziotinib
- type
- EXPERIMENTAL
- label
- Cohort 2: Poziotinib 16 mg
- description
- Participants received poziotinib 16 mg, administered as two 8 mg tablets, orally, QD, on a continuous dosing schedule in a 21-day cycle until disease progression, death, intolerable AEs or for up to a maximum of 24 months, whichever occurs first.
- interventionNames
- Drug: Poziotinib
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically confirmed primary breast cancer with metastatic lesions. 2. Confirmed HER2 overexpression or gene-amplified tumor 3. At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine 4. Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1) 5. Participant is at least 18, and ≤90 years of age. 6. Adequate hematologic, hepatic, and renal function 7. Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 Exclusion Criteria: 1. Previous treatment with poziotinib prior to study participation 2. Brain metastases that are 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 15 days of enrollment. 3. Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or investigational treatment within 15 days, except for hormone therapy, palliative therapy, or supportive therapy. 4. History of congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment. 5. Cardiac ejection fraction \<50% 6. History of other malignancies within the last 5 years 7. Participant is pregnant or breast-feeding. 8. Unable to take drugs orally
References
Publications (0)
Data not yet available
No reference posted for this study.