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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
Sponsor:
Information provided by (Responsible Party):
Yeon Hee Park, Samsung Medical Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Poziotinib
12mg P.O. for 2wks q21days
Drug: Poziotinib
12mg P.O. for 2wks q21days
Other Name: HM781-36B




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 1 years ]
  2. duration of response [ Time Frame: 1 years ]
  3. objective response rate [ Time Frame: 1 years ]
  4. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 years ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed metastatic breast cancer with measurable or evaluable disease
  2. age ≥ 20 years
  3. HER2 mutation or EGFR mutation/gene amplification confirmed by CancerSCAN or Activated AR pathway confirmed by RNA seq & nCounter assay, AR expression was confirmed by immunohistochemistry(IHC) or EGFR high expression (≥ IHC 2+ & lower ER / ≥ IHC score + and HER2 2+ or SISH negative)
  4. ECOG performance status 0 - 2
  5. Two or more regimens for locally recurrent or metastatic breast cancer, including an anthracycline and a taxane
  6. Life expectancy ≥ 3 months
  7. Progression within 6 months or less of latest chemotherapy
  8. The patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior radiotherapy must be completed 2 weeks before study entry.
  9. Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
  10. Adequate renal function (serum creatinine ≤ 1.5 x upper normal limit or CCr ≥ 50 ml/min)
  11. Adequate liver function (serum bilirubin ≤ 1.5 x upper normal limit, AST/ALT ≤ 3 x upper normal limit)
  12. No prior history of pan-HER TKI including poziotinib for metastatic breast cancer
  13. Written informed consent

Exclusion Criteria:

  1. HER2-overexpressing breast cancer
  2. Serious uncontrolled intercurrent infections
  3. Serious intercurrent medical or psychiatric illness, including active cardiac disease
  4. Pregnancy or breast feeding
  5. Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or resected thyroid papillary carcinoma or other malignancy treated at least 5 years previously with no evidence of recurrence)
  6. Documented leptomeningeal brain metastasis
  7. Known brain metastases unless treated and stable
  8. Peripheral neuropathy ≥ grade 3
  9. Prior treatment with pan-HER TKI including poziotinib will not be allowed.
  10. Use of any investigational drug within 4 weeks of the study
  11. Treatment with chemotherapy or hormone therapy within 3 weeks of the study

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Yeon Hee Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02544997    
Other Study ID Numbers: 2014-11-078
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases