NCT02720185

Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR

Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers With Nuclear Epidermal Growth Factor Receptor (nEGFR)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. To examine the safety and tolerability of dasatinib in patients with operable TNBC 2. To explore potential intracellular mechanisms which impact dasatinib effect on cellular localization of EGFR in operable TNBC. 3. To examine the pathologic complete response (pCR) rates to standard neoadjuvant chemotherapy in nEGFR+ TNBC 4. To examine breast cancer recurrence rates and patterns of metastatic recurrent in nEGFR+ TNBC

Conditions

• Breast Neoplasms
• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Dasatinib	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	Undergo surgery
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-05-03
• Primary completion: 2020-07-02
• Completion: 2022-02-08
• First posted: 2016-03-25
• Last updated: 2022-06-03
• Results posted: 2022-02-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study