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Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Metastatic Cancer

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Trial Information

Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone Metastasis Predominant Metastatic Breast Cancer


- Compare the progression-free survival of patients with stage IV bone
metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of

- Compare the response rate (complete and partial, confirmed and unconfirmed) in patients
treated with these regimens.

- Compare the MUC-1 antigen response rate (CA 15-3 or CA 27-29) in patients treated with
these regimens.

- Compare the circulating tumor cell response rate in patients treated with these

- Compare the anti-osteoclast activity, as measured by changes in bone turnover markers,
in patients treated with these regimens.

- Compare the frequency and severity of toxicities of these regimens in these patients.

- Compare the pain profiles of these patients and explore changes over time.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
concurrent trastuzumab (Herceptin®) treatment (yes vs no). Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive oral dasatinib once daily.

- Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment
continues for at least 24 weeks in the absence of disease progression or unacceptable

Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24. Samples
are analyzed for tumor markers, circulating tumor cells, and bone markers.

Patients complete a self-reported brief pain inventory questionnaire at baseline and once in
weeks 8, 16, and 24.

After completion of study treatment, patients are followed every 3-6 months for up to 2

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Inclusion Criteria


- Diagnosis of breast carcinoma meeting the following criteria:

- Stage IV disease

- Bone metastasis-predominant disease, defined as the presence of ≥ 1 bone
metastasis with or without nonbone (visceral or soft tissue) disease where the
number of bone metastases is at least the number of measurable visceral target

- Visceral disease that does not cause a reduction in ECOG performance status

- Must meet 1 of the following criteria:

- Measurable disease within the past 28 days

- Nonmeasurable disease with rising serum CA 15-3, CA 27-29, CEA, or CA-125
documented by 2 consecutive measurements taken ≥ 14 days apart with the most
recent measurement being within the past 42 days

- These measurements need not be consecutive, and the prior measurement could
have been months to years prior to the current measurement if the marker is
considered by the investigator to reflect disease progression

- The second serum marker value must be greater than the institution's upper
limit of normal and show ≥ a 20% increase over the first measurement

- No symptomatic brain or CNS metastases

- Prior CNS or brain metastasis allowed provided it was treated with radiotherapy
≥ 8 weeks ago

- No pleural or pericardial effusion

- Hormone receptor status known

- Estrogen receptor- and/or progesterone receptor-positive disease must have
progressed on ≥ 1 hormonal therapy in the metastatic setting


- Male or female

- Menopausal status not specified

- Zubrod performance status 0-2

- QTc < 450 msec by EKG

- Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram with no significant
abnormalities within the past 12 weeks for patients on trastuzumab

- No active infection requiring systemic therapy

- No uncontrolled concurrent condition that would preclude the ability to take oral
medication, including the following:

- Nausea

- Vomiting

- Diarrhea

- Lack of physical integrity of the upper gastrointestinal tract

- Malabsorption syndrome

- No clinically significant cardiac disease, including the following:

- Congestive heart failure

- Symptomatic coronary artery disease

- Cardiac arrhythmias not well controlled

- Myocardial infarction within the past 12 months

- No concurrent active malignancy

- Prior malignancies allowed provided the patient is currently disease-free

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 3 months after
completion of study therapy


- See Disease Characteristics

- No prior RankL inhibitor therapy

- No more than 1 prior cytotoxic chemotherapy for metastatic disease

- At least 3 weeks since prior chemotherapy and recovered

- At least 1 week since prior radiotherapy to non-CNS disease and recovered

- At least 3 weeks since prior and no concurrent intravenous bisphosphates (e.g.,

- At least 7 days since prior and no concurrent antiplatelet agents, including any of
the following*:

- Anticoagulants (e.g., tirofiban, eptifibatide, ticlopidine)

- Aspirin or aspirin-containing combinations

- Dipyridamole

- Epoprostenol

- Clopidogrel

- Cilostazol

- Abciximab NOTE: *Nonsteroidal anti-inflammatory drugs and medically indicated
platelet-inhibiting medication allowed

- At least 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the

- HIV protease inhibitors (e.g., amprenavir, atazanavir, fosamprenavir, indinavir,
nelfinavir, ritonavir)

- Select antibiotics (e.g., ciprofloxacin, clarithromycin, doxycycline, enoxacin,
isoniazid, telithromycin)

- Azole antifungals (e.g., itraconazole, ketoconazole, miconazole, voriconazole)

- Select anesthetics (e.g., ketamine, propofol)

- Hypericum perforatum (St. John's wort)

- Nefazodone

- Nicardipine

- Diclofenac

- Quinidine

- Imatinib mesylate

- At least 7 days since prior and no concurrent medications that prolong the QTc
interval, including any of the following:

- Antiarrhythmic agents (e.g., quinidine, procainamide, disopyramide phosphate,
amiodarone, sotalol hydrochloride, ibutilide, dofetilide)

- Antipsychotic agents (e.g., chlorpromazine, mesoridazine, thioridazine,
pimozide, haloperidol, droperidol)

- Select antibiotics (e.g., erythromycin, clarithromycin, sparfloxacin,

- Narcotic analgesics (e.g., levomethadyl, methadone, domperidone)

- Calcium channel blockers (e.g., bepridil, lidoflazine)

- Antimalarial agents (e.g., halofantrine, chloroquine)

- Parasympathomimetic agents (e.g., cisapride)

- Arsenic trioxide

- No other concurrent antineoplastic therapy for breast cancer, including any of the

- Radiotherapy

- Chemotherapy

- Immunotherapy

- Biologic therapy

- Hormonal therapy

- Gene therapy

- No concurrent grapefruit juice consumption

- No concurrent short-acting antacid agents within 2 hours of dasatinib administration

- Concurrent trastuzumab (Herceptin®) therapy for HER-2 positive patients allowed
provided patients have been on continuous trastuzumab for ≥ 12 weeks

Type of Study:


Study Design:

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

Outcome Measure:

Progression-free survival, with disease progression defined as an increase in measurable disease, the appearance of new lesions, and/or clinical deterioration related to disease progression

Outcome Description:

Time from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.

Outcome Time Frame:

Disease assessed every 8 weeks for up to 2 years until progression.

Safety Issue:


Principal Investigator

Anne F. Schott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Metastatic Cancer
  • stage IV breast cancer
  • male breast cancer
  • recurrent breast cancer
  • bone metastases
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



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