Efficacy Study of Dasatinib in Locally Advanced Triple-Negative Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Dasatinib
Intervention description: pill form, 100 mg daily
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      We want to learn if dasatinib will make triple negative breast cancers smaller. We also hope
      that we can learn more about what makes triple negative breast cancers grow. We believe this
      information will help us to predict which patients will benefit from taking this drug or
      other drugs like it.

      This study is a "neoadjuvant study", which means that it is only open to women who have not
      had any treatment for their breast cancer. Neoadjuvant studies allow the study doctor to look
      at how the cells in your cancer change after taking the study medication. This will help us
      to understand whether or not dasatinib is an effective treatment for breast cancer. It will
      also help us to learn more about triple negative breast cancer and how to treat it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women diagnosed with triple negative breast cancer (breast cancer is not estrogen
             receptor positive (ER+), progesterone receptor positive (PgR+) or human epidermal
             growth factor receptor positive (HER2+)

               1. Clinical stage II or stage III invasive mammary carcinoma, confirmed by
                  histological analysis, as defined in the study protocol.

               2. Subject's age must be greater than or equal to 18 years.

               3. ECOG Performance Status of 0-1.

               4. Subjects must have measurable* tumor at the primary site. *Measurable disease is
                  defined as follows: Any mass that can be reproducibly measured by physical
                  examination, mammogram, and/or ultrasound and can be accurately measured in at
                  least one dimension (longest diameter to be recorded) as 10 mm (1 cm).

               5. No history of prior chemotherapy for primary breast cancer.

               6. Patients with a prior history of contralateral breast cancer are eligible if they
                  have no evidence of recurrence of their initial primary breast cancer within the
                  past 5 years.

               7. Women may have been taking tamoxifen or raloxifene as a preventive agent prior to
                  study entry but must have discontinued the drug for at least 21 days prior to
                  study enrollment.

               8. Adequate organ function, as defined by the following: a) Total bilirubin < 2.0
                  times the institutional Upper Limit of Normal (ULN) b) Hepatic enzymes (AST, ALT
                  ) ≤ 2.5 times the institutional ULN c) Serum sodium, potassium, magnesium,
                  phosphate, and calcium levels greater than or equal to the Lower Limit of Normal
                  (LLN). d) Serum Creatinine < 1.5 time the institutional ULN e) Hemoglobin,
                  Neutrophil count, Platelets, PT, PTT all Grade 0-1, as defined by the NCI CTCAE
                  v3.0.

               9. Ability to swallow and retain oral medications (dasatinib must be swallowed
                  whole).

              10. Subject must not be taking any prohibited medications, as defined in Section 6.5
                  of the study protocol.

              11. Women of childbearing potential (WOCBP) must have a negative serum or urine
                  pregnancy test (sensitivity < 25 IU/L) within 72 hours prior to beginning study
                  medication.

              12. WOCBP must agree to utilize an adequate method of contraception throughout
                  treatment, and for at least 4 weeks after stopping study medication. 13. Signed,
                  written informed consent, including a HIPAA form, as per institutional
                  guidelines.

        Exclusion Criteria:

          1. Locally recurrent breast cancer.

          2. History of prior chemotherapy for breast cancer.

          3. History of malignancy requiring radiotherapy or systemic treatment within the past 5
             years.

          4. Presence of any concurrent medical condition that would increase the risk of toxicity,
             including the following: •Pleural or pericardial effusion of any grade •Uncontrolled
             angina •Congestive heart failure •Myocardial infarction within the past 6 months
             •Diagnosed congenital long QT syndrome •Any history of clinical significant
             ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or
             Torsades de pointes) •Prolonged QTc interval (> 450 ms) on pre-study ECG
             •Uncorrectable hypokalemia or hypomagnesia •Significant bleeding disorder unrelated to
             cancer, including: - History of congenital bleeding disorders (e.g. von Willebrand's
             disease) - Acquired bleeding disorder that has been diagnosed within the past year
             (e.g. acquired anti-factor VIII antibodies) - Ongoing or recent (less than or equal to
             3 months) significant gastrointestinal bleeding.

          5. Subjects taking any prohibited medications will be excluded from study, as defined in
             Section 6.5 of the study protocol.

          6. WOCBP who are pregnant or breastfeeding or who are unwilling to use an acceptable
             method of contraception for the duration of study therapy and for at least 4 weeks
             after cessation of study drug.

          7. Active or uncontrolled infection.

          8. Dementia, altered mental status, or any psychiatric condition that would prohibit the
             understanding or rendering of informed consent.