Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR
NCT02720185 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2022-06-03
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
- DRUG
-
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
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of Wisconsin, Madison
lead OTHER
Principal Investigators
-
Kari B Wisinski, MD · University of Wisconsin, Madison
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-03
- Primary Completion
- 2020-07-02
- Completion
- 2022-02-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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