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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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02544997
Collaborator
(none)
5
Enrollment
1
Location
1
Arm
53
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Sep 1, 2015
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Poziotinib

12mg P.O. for 2wks q21days

Drug: Poziotinib
12mg P.O. for 2wks q21days
Other Names:
  • HM781-36B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [1 years]

    Secondary Outcome Measures

    1. overall survival (OS) [1 years]

    2. duration of response [1 years]

    3. objective response rate [1 years]

    4. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [1 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yeon Hee Park, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT02544997
    Other Study ID Numbers:
    • 2014-11-078
    First Posted:
    Sep 9, 2015
    Last Update Posted:
    Jul 7, 2020
    Last Verified:
    Jul 1, 2020
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 7, 2020