Clinical Trials /

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

NCT02544997

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 2014-11-078
  • NCT ID: NCT02544997

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
PoziotinibHM781-36BPoziotinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
PoziotinibExperimental12mg P.O. for 2wks q21days
  • Poziotinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:1 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:overall survival (OS)
Time Frame:1 years
Safety Issue:
Description:
Measure:duration of response
Time Frame:1 years
Safety Issue:
Description:
Measure:objective response rate
Time Frame:1 years
Safety Issue:
Description:
Measure:Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame:1 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

Last Updated

January 16, 2018