Ado-Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Biological: Trastuzumab Emtansine
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Thrombokinetic Studies of Ado-Trastuzumab Emtansine|
- Platelet function, measured using a bleeding time test [ Time Frame: Up to 30 days ]
- Thrombokinetic changes [ Time Frame: Baseline up to 30 days ]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.
- 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 partial response), or maintain stable disease for at least 6 months from study entry, based on investigator assessment using RECIST v 1.1 [ Time Frame: Up to 2 years ]
- Death [ Time Frame: Up to 2 years ]
- Duration of objective response, based on investigator assessment using RECIST v.1.1 [ Time Frame: First tumor assessment that supports the patient's objective response until the time of disease progression or death from any cause, assessed up to 2 years ]
- Incidence of abnormal laboratory values [ Time Frame: Up to 30 days after completion of study treatment ]
- Incidence of AEs leading to study treatment discontinuation, modification, or interruption, graded according to the NCI CTCAE v4.0 [ Time Frame: Up to 30 days after completion of study treatment ]
- Incidence, type, and severity of adverse events (AEs) graded according to the NCI CTCAE v4.0 [ Time Frame: Up to 30 days after completion of study treatment ]
- LVEF [ Time Frame: Up to 2 years ]
- Objective response rate, based on investigator assessment using RECIST v. 1.1 [ Time Frame: Up to 2 years ]
- PFS assessed using RECIST v. 1.1 [ Time Frame: Time from study entry to the first occurrence of disease progression, or death from any cause, assessed up to 2 years ]
|Study Start Date:||June 2014|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ado-trastuzumab emtansine)
Patients receive ado-trastuzumab emtansine 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.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
Correlative studiesBiological: Trastuzumab Emtansine
I. To assess change in thrombokinetics (platelet circulation life span).
I. To evaluate the progression free survival (PFS), duration of response, benefit rate (as defined by stable disease, partial response, or complete response by Response Evaluation Criteria in Solid Tumors [RECIST] v 1.1), overall response rate (as defined by partial or complete response by RECIST v 1.1), and survival.
II. To evaluate the safety of ado-trastuzumab emtansine (non-platelet toxicity).
III. To evaluate the pharmacokinetics of ado-trastuzumab emtansine.
Patients receive ado-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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01816035
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Breast Oncology Research Team 206-288-6329 firstname.lastname@example.org|
|Principal Investigator: Vijayakrishna K. Gadi|
|Principal Investigator:||Vijayakrishna Gadi||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|