S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone

DISEASE CHARACTERISTICS:

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 lesions

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

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT 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., zoledronate)

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 following:

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, pentamidine)
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 following:

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