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Protocol No. UW15114

Principal Investigator Wisinski, Kari

Phase II

Age Group Adult

Scope Local

Sponsor Type Externally Peer-Reviewed; Institutional

Title A Window of Opportunity Study of Dasatinib in Operable Triple Negative Breast Cancers with Nuclear Epidermal Growth Factor Receptor

Objective Triple negative breast cancer may be influenced by something called "Epidermal Growth Factor Receptor"(EGFR). Current research has shown that although EGFR is identified, medications blocking EGFR do not have much effect for triple negative breast cancer. Researchers think this is because EGFR may not be in the correct location in the cell (in the nucleus rather than the plasma menbrane) and that this causes resistance. Treatment with a medication targeting another component of the cell called Src may help keep EGFR in the correct place. This medication is called dasatinib. This study is being done to determine if dasatinib can keep the EGFR in the correct location. We also want to make sure treatment with dasatinib is safe and tolerable for patients with TNBC who have surgery. In the future, this may allow new combination therapies to be studied for triple negative breast cancers that are identified to have EGFR in the nucleus.

Treatment Dasatinib is an oral tyrosine kinase inhibitor.

Description You will start treatment with dasatinib 7-10 days before your planned surgery to remove your TNBC. Dasatinib is a pill that you would take once a day until the surgery. Tissue from your surgery will be used by the researchers to do further testing related to the study. Approximately 30 days after your surgery you will be asked to return to the clinic for one more study related clinic visit, which will also include additional laboratory tests.

Key Eligibility
  • Patients must have histologically or cytologically confirmed Stage I- III triple negative breast cancer
  • nEGFR positive
  • No prior therapy for current breast cancer
  • Meet criteria for neoadjuvant chemotherapy or primary breast surgery, as determined by primary oncologist and surgeon
  • Women age ≥18 years
  • Patients who are receiving any other investigational agents are ineligible
  • H2 antagonists and proton pump inhibitors are not allowed
  • Anticoagulants (ie. Coumadin, heparin, anti-Xa inhibitors) and anti-platelet agents (ie. aspirin) are not allowed. NSAIDS and acetaminophen are allowed on study
  • Pregnant women are excluded from this study
  • Breastfeeding should be discontinued if the mother is treated
  • with dasatinib and not resumed until at least 2 weeks after the final dose
  • HIV-positive patients on combination antiretroviral therapy are ineligible

Applicable Disease Sites Breast

Therapies Involved Other

Drugs Involved BMS354825 (dasatinib); Sprycel (dasatinib); dasatinib

Status Open

Participating Institutions UW Hospital and Clinics; University of Illinois Cancer Center