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 | Completed Phase 2

• 1 other identifier: 2014-11-078
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  1 years

Secondary Outcomes (4)

• overall survival (OS)

  1 years

• duration of response

  1 years

• objective response rate

  1 years

• Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

  1 years

Study Arms (1)

Poziotinib

EXPERIMENTAL

12mg P.O. for 2wks q21days

Drug: Poziotinib

Interventions

Poziotinib DRUG

12mg P.O. for 2wks q21days

Also known as: HM781-36B

Poziotinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic breast cancer with measurable or evaluable disease
• age ≥ 20 years
• 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)
• ECOG performance status 0 - 2
• Two or more regimens for locally recurrent or metastatic breast cancer, including an anthracycline and a taxane
• Life expectancy ≥ 3 months
• Progression within 6 months or less of latest chemotherapy
• 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.
• Adequate bone marrow function (≥ ANC 1,500/ul, ≥ platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
• Adequate renal function (serum creatinine ≤ 1.5 x upper normal limit or CCr ≥ 50 ml/min)
• Adequate liver function (serum bilirubin ≤ 1.5 x upper normal limit, AST/ALT ≤ 3 x upper normal limit)
• No prior history of pan-HER TKI including poziotinib for metastatic breast cancer
• Written informed consent

You may not qualify if:

• HER2-overexpressing breast cancer
• Serious uncontrolled intercurrent infections
• Serious intercurrent medical or psychiatric illness, including active cardiac disease
• Pregnancy or breast feeding
• 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)
• Documented leptomeningeal brain metastasis
• Known brain metastases unless treated and stable
• Peripheral neuropathy ≥ grade 3
• Prior treatment with pan-HER TKI including poziotinib will not be allowed.
• Use of any investigational drug within 4 weeks of the study
• Treatment with chemotherapy or hormone therapy within 3 weeks of the study

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

HM781-36B

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 9, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

KR (1)