Study terminated early due to COVID-19 related slow enrollment and funding
Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor (nEGFR)
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI Trial ID
OTHER · Institutional Review Board
OTHER · UW Madison
OTHER · UW Madison
OTHER · UW Madison
interventional
5
1 country
2
Study Start
May 3, 2017
Actual (reported)Primary Completion
July 2, 2020
Actual (reported)Study Completion
February 8, 2022
Actual (reported)Primary Objective: To determine if dasatinib, an inhibitor of the Src family kinases, can prevent the nuclear translocation of the epidermal growth factor receptor (EGFR) in Stage I-III, nuclear EGFR positive, triple negative breast cancers (TNBC). Secondary Objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 8, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2016
Actual (reported)March 25, 2016
Actual (reported)May 3, 2017
Actual (reported)July 2, 2020
Actual (reported)February 8, 2022
Actual (reported)February 25, 2022
Actual (reported)Plasma Membrane Epidermal Growth Factor Receptor (EGFR) Expression, Measured by VECTRA Imaging
An increase of at least 25% from baseline to post-dasatinib treatment will be considered significant. VECTRA is an automated pathology imaging system used to detect biomarkers in samples.
7-10 days
Number of Treatment-emergent Adverse Events [Safety and Tolerability] up to 4 Weeks
Up to 4 weeks
Number of Participants With Pathologic Complete Response (pCR)
Up to 4 weeks
Number of Participants With No Evidence of Disease (NED) at Long-term Follow up
up to 24 months
Dasatinib 100mg for 7-10 days until day prior to surgery
100mg oral once daily dasatinib taken for 7-10 days up to the day prior to planned surgery or research biopsy (neoadjuvant chemotherapy group)
Undergo surgery
University of Illinois Hospital and Health Systems (Outpatient Care Center)
Chicago, Illinois, 60612, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705, United States
Statistical analyses were not completed for this study as it was not powered for meaningful results. Study was terminated early due to pandemic related enrollment issues, participants moved on to other therapies compromising intervention-relevant long term AE follow up.
Kari B Wisinski, MD
University of Wisconsin, Madison
5 participants (actual enrollment reported by the registry).
First Submitted
March 21, 2016
First Posted
March 25, 2016
Study Start
May 3, 2017
Actual (reported)Primary Completion
Correlative studies
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
July 2, 2020
Actual (reported)Study Completion
February 8, 2022
Actual (reported)Last Updated
June 3, 2022
Results First Posted
February 25, 2022
Record last verified: 2022-06
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Source: ClinicalTrials.gov.
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