A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway
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|ClinicalTrials.gov Identifier: NCT02544997|
Recruitment Status : Completed
First Posted : September 9, 2015
Last Update Posted : July 7, 2020
Metastatic breast cancer (MBC) is an incurable disease and is needed to improve effective therapeutic strategies including targeted agents.
Poziotinib is a panHER tyrosin kinase inhibitor (TKI) that showed stable activity with feasible toxicity for MBC patients as a salvage treatment strategy after failure of anthracycline and taxane in phase I trial. Poziotinib has rational benefit compared with other salvage agents, especially for patients with HER2 overexpression breast cancers. Additionally, a recent report showed that possible rational background for patients with HER2 mutation-positive breast cancers.
Based on this rationale, the investigators are to conduct phase II single-arm study of poziotinib for patients with MBC who showed refractoriness to conventional treatments as salvage treatment.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Poziotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Single-Arm Trial of Poziotinib as Salvage Treatment in Patients With Metastatic Breast Cancer Who Has HER2 or EGFR Mutation or Activated AR or EGFR Pathway|
|Actual Study Start Date :||September 2015|
|Actual Primary Completion Date :||February 2020|
|Actual Study Completion Date :||February 2020|
12mg P.O. for 2wks q21days
12mg P.O. for 2wks q21days
Other Name: HM781-36B
- Progression free survival (PFS) [ Time Frame: 1 years ]
- overall survival (OS) [ Time Frame: 1 years ]
- duration of response [ Time Frame: 1 years ]
- objective response rate [ Time Frame: 1 years ]
- Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544997
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|