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Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Short-term Adjuvant Therapy and Biomarker Studies With Targeted Agents in Women With Estrogen Receptor Negative Breast Cancer

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 3 study groups:

- If you are in Group 1, you will take dasatinib 40mg once a day by mouth with water.

- If you are in Group 2, you will take dasatinib 80mg once a day by mouth with water.

- If you are in Group 3, you will not receive dasatinib.

You will be given a study drug diary to complete. In the diary, you will record when you
take the study drug.

Study Visits:

At Month 1:

- Blood (about 2 tablespoons) will be drawn for routine tests.

- You will be asked about any drugs you may be taking and side effects you may be having.

- Your drug diary will be reviewed.

- At Month 2 you will be called by a nurse and asked about any drugs you are taking and
side effects you may be having. You will also be asked to review your drug diary. This
call will take about 20 minutes

At Month 3 (or if you leave the study early):

- You will have a fine needle aspirate (FNA) of the breast for biomarker testing.
Biomarkers are found in the blood/tissue and may be related to your reaction to the
study drug.

- Blood (about 2-3 tablespoons) will be drawn for biomarker testing.

- You will be asked about any drugs you may be taking and side effects you may be having.

- Your drug diary will be reviewed.

Length of Study:

You may remain on study for up to 3 months. You will no longer be able to take the study
drug if the disease gets worse, if intolerable side effects occur, or if you are unable to
follow study directions.

This is an investigational study. Dasatinib is FDA approved and commercially available for
the treatment of leukemia. Its use in breast cancer patients in investigational.

Up to 66 patients will take part in this multicenter study. Up to 60 will be enrolled at MD

Inclusion Criteria:

1. Histological confirmation of ER negative breast carcinoma, stage I, II, or III

2. Completed all adjuvant therapy including (if indicated) endocrine, trastuzumab,
radiation therapy

3. At least 18 years of age.

4. Provided written informed consent.

5. Adequate bone marrow function: 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).

6. Normal mammogram of unaffected breast within 12 months prior to study entry.

7. 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 or hysterectomy, 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 oligomenorrhoea (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 IRB/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.

8. (Continued from above) • 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

9. Able to swallow and retain oral medication.

10. ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.

11. Serum creatinine < 1.4 mg/dL or calculated creatinine clearance (CrCl) >/= 60 mL/min

12. Aspartate and alanine transaminase (AST or ALT) reference range.

13. Patients must have a baseline ECG with QTc within the normal range within 28 days
prior to registration.

14. Total bilirubin
Exclusion Criteria:

1. Uncontrolled angina, congestive heart failure, MI (within last 6 months), congenital
long QT syndrome, history of clinically significant ventricular arrhythmia, prolonged
QTc interval on pre-entry EKG (greater than normal range)

2. Has evidence of recurrent or metastatic (Stage IV) breast cancer.

3. Is a pregnant or lactating female.

4. Has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to

5. Has received treatment with any investigational drug in the previous 4 weeks.

6. Has received chemotherapy, immunotherapy, biologic therapy or endocrine therapy
within the past 12 weeks.

7. Contraindication to RPFNA including breast implant(s), bilateral radiation,

8. Unwillingness to undergo RPFNA.

9. Is considered medically unfit for the study by the investigator as a result of the
medical interview, physical exam, or screening investigations.

10. Is currently receiving oral steroid treatment (inhaled steroids are permitted)

11. Oral estrogen, progesterone, testosterone therapy within last 3 months.

12. 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)

13. Hypokalemia or hypomagnesemia if it cannot be corrected

14. Concomitant Medications, consider the following prohibitions (Drugs must be
discontinued for 7 days prior to starting protocol therapy): Drugs that are generally
accepted to have a risk of causing Torsades de Pointes including : quinidine,
procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide erythromycins,
clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide,
cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,
halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. The concomitant
use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The
use of antacids should be considered in place of H2 blockers or proton pump
inhibitors in patients receiving dasatinib therapy. Patient agrees to discontinue St.
Johns Wort while receiving dasatinib therapy

15. Patient may not be receiving any prohibited CYP3A4 inhibitors

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Change in Ki-67 in Breast Tissue of High-Risk Women

Outcome Description:

Primary endpoint is the change in Ki-67 before and after 3 months of dasatinib treatment in breast tissue of high-risk women. Ki-67 is measured as a continuous variable and a one-way ANOVA followed by Dunnett's multiple comparison test comparing the change of Ki-67 of each of the three treated groups with control. The purpose of this study is to determine the minimum biological effective dose, which is defined as the lowest dose where the change of Ki-67 is significantly different from that in the control group.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Banu Arun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Estrogen Receptor Negative Breast Cancer
  • Biomarker studies
  • Ki-67
  • Dasatinib
  • BMS-354825
  • Sprycel
  • Breast Neoplasms



Duke University Durham, North Carolina  27710
UT MD Anderson Cancer Center Houston, Texas  77030