Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR
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|ClinicalTrials.gov Identifier: NCT02720185|
Recruitment Status : Suspended (Recruitment suspended due to COVID-19)
First Posted : March 25, 2016
Last Update Posted : May 20, 2020
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).
- To examine the safety and tolerability of dasatinib in patients with operable TNBC
- To explore potential intracellular mechanisms which impact dasatinib effect on cellular localization of EGFR in operable TNBC.
- To examine the pathologic complete response (pCR) rates to standard neoadjuvant chemotherapy in nEGFR+ TNBC
- To examine breast cancer recurrence rates and patterns of metastatic recurrent in nEGFR+ TNBC
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms Triple Negative Breast Neoplasms||Drug: Dasatinib Procedure: Conventional Surgery Other: Laboratory Biomarker Analysis||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor|
|Actual Study Start Date :||May 3, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Dasatinib 100mg
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)
Procedure: Conventional Surgery
Other: Laboratory Biomarker Analysis
- Increase in plasma membrane EGFR expression, measured by VECTRA [ Time Frame: 7-10 days ]An increase of at least 25% from baseline to post-dasatinib treatment will be considered significant.
- Incidence of treatment-emergent adverse events [safety and tolerability] [ Time Frame: Up to 4 weeks ]Safety and tolerability of dasatinib in participants with operable TNBC will be based on NCIC Adverse Events Version 4.0 and will be assessed by frequency tables.
- Pathologic Complete Response (pCR) [ Time Frame: Up to 4 weeks ]Examine pCR rates to standard neoadjuvant chemotherapy in nEGFR+ TNBC. pCR will be defined as ypT0 ypNO (absence of cancer in breast tissue and lymph nodes) an assessed by the investigator. The point estimate of pCR and it's exact 95% confidence intervals will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720185
|United States, Illinois|
|University of Illinois Hospital and Health Systems (Outpatient Care Center)|
|Chicago, Illinois, United States, 60612|
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Kari B Wisinski, MD||University of Wisconsin, Madison|