Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least two prior HER2-directed treatment regimens.

Key facts

Study ID

NCT02659514

Run by

Spectrum Pharmaceuticals, Inc

People needed

67

Starts

2016-02-22

Expected to finish

2020-03-11

Last updated by the study team

2022-03-11

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histopathologically confirmed primary breast cancer with metastatic lesions.
• Confirmed HER2 overexpression or gene-amplified tumor
• At least two prior HER2-directed therapy regimens for breast cancer, including trastuzumab and trastuzumab emtansine
• Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
• Participant is at least 18, and ≤90 years of age.
• Adequate hematologic, hepatic, and renal function
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2

You may not qualify if…

• Previous treatment with poziotinib prior to study participation
• Brain metastases that are symptomatic or require therapy to control symptoms, as well as any history of radiation, surgery, or other therapy, including steroids, to control symptoms from brain metastases within 15 days of enrollment.
• Anticancer chemotherapy, biologics, immunotherapy, cure-intent radiotherapy, or investigational treatment within 15 days, except for hormone therapy, palliative therapy, or supportive therapy.
• History of congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
• Cardiac ejection fraction <50%
• History of other malignancies within the last 5 years
• Participant is pregnant or breast-feeding.
• Unable to take drugs orally

Where it is running

• Clearview Cancer Center — Huntsville, Alabama, United States
• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• Marin Cancer Care, Inc — Greenbrae, California, United States
• Alliance Research Centers — Laguna Hills, California, United States
• PacificShores Medical Group — Long Beach, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• AMPM Research Clinic — Miami Gardens, Florida, United States
• FL Cancer Research Institute — Plantation, Florida, United States
• Bond Clinic, P.A. — Winter Haven, Florida, United States
• Triple Army Medical Cente — Honolulu, Hawaii, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• The University of Kansas Cancer Center and Medical Pavilion — Westwood, Kansas, United States
• Hattiesburg Clinic Hematology Oncology — Hattiesburg, Mississippi, United States
• Washington University — St Louis, Missouri, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• North Shore Hematology Oncology Associates — East Setauket, New York, United States
• Hudson Valley Hematology Oncology Associates — Poughkeepsie, New York, United States
• White Plain Hospital — White Plains, New York, United States
• Waverly Hematology Oncology — Cary, North Carolina, United States
• Aultman Hospital — Canton, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Oklahoma Cancer Specialists & Research Institute, LLC — Tulsa, Oklahoma, United States
• Magee Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Charleston Cancer Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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