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.
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
Interventions
Drug | Synonyms | Arms |
---|
Poziotinib | HM781-36B | Poziotinib |
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
Name | Type | Description | Interventions |
---|
Poziotinib | Experimental | 12mg P.O. for 2wks q21days | |
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: | Completed |
Lead Sponsor: | Samsung Medical Center |
Last Updated
July 7, 2020