Brief Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline

Completed

Started Mar 2007

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

117 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

First Submitted

Initial submission to the registry

December 11, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed

3 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed

5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed

3.5 years until next milestone

Results Posted

Study results publicly available

July 2, 2017

Completed

Last Updated

July 2, 2017

Status Verified

May 1, 2017

Enrollment Period

5.8 years

First QC Date

December 11, 2006

Results QC Date

January 13, 2014

Last Update Submit

May 31, 2017

Conditions

Breast Cancer Metastatic Cancer

Keywords

stage IV breast cancermale breast cancerrecurrent breast cancerbone metastases

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
RECIST progression defined as 20% increase in the sum of longest diameters of target measurable lesions over the smallest sum observed, unequivocal progression of non-measurable disease, the appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration, development of one or more new bone lesions from baseline, or symptomatic deterioration related to disease progression. 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.
Up to 2 years

Secondary Outcomes (11)

Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Up to 2 years
MUC-1 Antigen Response
at 4, 8, 16, and 24 weeks
Circulating Tumor Cells (CTC) Response Rate
Up to 4 weeks
Change in Serum Bone Turnover Markers Over Time -- NTx
at baseline, 4, and 8 weeks
Change in Serum Bone Turnover Markers Over Time -- BAP
at baseline, 4, and 8 weeks
+6 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral dasatinib once daily.

Drug: dasatinib

Arm II

EXPERIMENTAL

Patients receive oral dasatinib twice daily.

Drug: dasatinib

Interventions

dasatinibDRUG

given orally

Arm IArm II

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (117)

Providence Cancer Center at Providence Hospital

Mobile, Alabama, 36608, United States

Location

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Highlands Oncology Group - Springdale

Bentonville, Arkansas, 72712, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, 95901, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus