This phase I trial studies the side effects and best way of giving trastuzumab emtansine in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to other parts of the body or nearby tissue and cannot be removed by surgery. Biological therapies, such as trastuzumab emtansine, may stimulate the immune system in different ways and stop cancer cells from growing.
PRIMARY OBJECTIVES: I. To assess change in thrombokinetics (platelet circulation life span). SECONDARY OBJECTIVES: I. Benefit rate (as defined by stable disease, partial response, or complete response by Response Evaluation Criteria in Solid Tumors \[RECIST\] v 1.1) at the end of study activities. II. To evaluate the safety of trastuzumab emtansine (ado-trastuzumab emtansine) (non-platelet toxicity). III. To evaluate the pharmacokinetics of ado-trastuzumab emtansine. OUTLINE: Patients receive trastuzumab emtansine intravenously (IV) over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving response may continue treatment. After completion of study treatment, patients are followed up periodically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Platelet function, measured using a bleeding time test
Time frame: Up to 30 days
Thrombokinetic changes
The actual analysis will fit a linear mixed effects model, using a two-sided Wald test to compare pre-therapy to the two post-therapy values, and should have greater power than a matched pairs design. Also, platelet lifespan may be measured in absolute terms (platelet lifespan) or relative terms (percentage relative to pre-therapy lifespan), and may be transformed to decrease the influence of extreme values.
Time frame: Baseline up to 30 days
Cause of death
Time frame: Up to 2 years
Clinical benefit rate
Defined as the proportion of patients who achieve an objective response (complete response or stable disease) based on investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1 criteria at the conclusion of study procedures.
Time frame: Up to 2 years
Death
Time frame: Up to 2 years
Incidence of abnormal laboratory values
Time frame: Up to 30 days after completion of study treatment
Incidence of adverse events leading to study treatment discontinuation, modification, or interruption, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days after completion of study treatment
Incidence, type, and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days after completion of study treatment
Incidence, type, and severity of severe adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time frame: Up to 30 days after completion of study treatment
Left ventricular ejection fraction
Time frame: Up to 2 years
Objective response rate, based on investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1
Time frame: Up to 2 years
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