Dasatinib in Preventing Second Primary Breast Cancer in Women with Estrogen Receptor Negative Breast Cancer

Inclusion Criteria

• Histological confirmation of ER negative breast carcinoma (defined as less than 10%), stage I, II, or III
• Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab, radiation therapy
• Female: A female is eligible to enter and participate in the study if she is of: a. non-childbearing potential (i.e., women with functioning ovaries who have a current documented tubal ligation, hysterectomy alone, hysterectomy and bilateral salpingo-oophorectomy, bilateral salpingo-oophorectomy alone or women who are post-menopausal); or b. childbearing potential (i.e., women with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility; this category includes women with oligomenorrhea (severe), women who are perimenopausal, and young women who have begun to menstruate), has a negative serum pregnancy test at screening, and agrees to one of the following where considered acceptable to the local Institutional Review Board (IRB)/Independent Ethics Committee (IEC): * Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm) * Abstinence from sexual intercourse from 2 weeks prior to administration of the investigational product, throughout the active study treatment period * Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject * Any intrauterine device (IUD) * Barrier methods including diaphragm or condom with a spermicide
• Able to swallow and retain oral medication
• ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2
• Provided written informed consent
• Hemoglobin >= 9 gm/dL
• Absolute granulocyte count >= 1,500/mm^3 (1.5 x 10^9/L)
• Platelets >= 75,000/mm^3 (100 x 10^9/L)
• Serum creatinine < 1.4 mg/dL or calculated creatinine clearance (CrCl) >= 30 mL/min
• Total bilirubin =< 1.5 times the upper limit of the reference range
• Aspartate and alanine aminotransferase (AST or ALT) =< 2 times the upper limit of the reference range
• Patients must have a baseline electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) within the normal range within 28 days prior to registration
• Normal mammogram of unaffected breast within 12 months prior to study entry

Exclusion Criteria

• Unwillingness to undergo RPFNA
• Contraindication to RPFNA including breast implant(s), bilateral radiation, anticoagulation (excluding those on 81 mg aspirin)
• Concurrent medical condition that would increase drug toxicity: pleural or pericardial effusion, coagulation or platelet function disorder, ongoing or recent (less than 3 months gastrointestinal bleeding)
• Uncontrolled angina, congestive heart failure, myocardial infarction (MI) (within last 6 months), congenital long QT syndrome, history of clinically significant ventricular arrhythmia, prolonged QTcF interval on pre-entry electrocardiogram (EKG) (greater than normal range)
• Hypokalemia or hypomagnesemia if it cannot be corrected
• Is a pregnant or lactating female
• Has evidence of recurrent or metastatic (stage IV) breast cancer
• Is considered medically unfit for the study by the investigator as a result of the medical interview, physical exam, or screening investigations
• Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to dasatinib
• Has received treatment with any investigational drug in the previous 4 weeks
• Has received chemotherapy, immunotherapy, biologic therapy or endocrine therapy within the past 12 weeks
• Is currently receiving oral steroid treatment (inhaled steroids are permitted)
• Oral estrogen, progesterone, testosterone therapy within last 3 months
• Concomitant medications: drugs that are considered category D (consider therapy modification) and X (avoid combination) using the Lexicomp database are prohibited; concomitant drugs that fall into categories A (no known interaction), B (no action needed) and C (monitor therapy) are allowed