S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone
- Registration Number
- NCT00410813
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
- Detailed Description
OBJECTIVES:
* Compare the progression-free survival of patients with stage IV bone metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of dasatinib.
* 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 regimens.
* 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 toxicity.
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 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I dasatinib Patients receive oral dasatinib once daily. Arm II dasatinib Patients receive oral dasatinib twice daily.
- Primary Outcome Measures
Name Time Method Progression-free Survival Up to 2 years 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.
- Secondary Outcome Measures
Name Time Method Circulating Tumor Cells (CTC) Response Rate Up to 4 weeks CTC response at 4 weeks is defined as the number of patients with initially elevated CTCs (\>= 5 cells/7.5 ml), whose CTC level drops to \< 5.
Change in Serum Bone Turnover Markers Over Time -- NTx at baseline, 4, and 8 weeks Analysis included mean values of the serum biomarker NTx at baseline, 4, and 8 weeks.
Change in Serum Bone Turnover Markers Over Time -- OC at baseline, 4, and 8 weeks Analysis included mean values of the serum biomarker OC at baseline, 4, and 8 weeks.
Change in Serum Bone Turnover Markers Over Time -- OPG at baseline, 4, and 8 weeks Analysis included mean values of the serum biomarker OPG at baseline, 4, and 8 weeks.
Response Rate (Complete and Partial, Confirmed and Unconfirmed) Up to 2 years Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms, normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed, unequivocal progression of non-measurable disease, appearance of any new lesion/site, death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Change in Serum Bone Turnover Markers Over Time -- BAP at baseline, 4, and 8 weeks Analysis included mean values of the serum biomarker BAP at baseline, 4, and 8 weeks.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Up to 2 years Only adverse events that are possibly, probably or definitely related to study drug are reported.
Mean Patient-reported Pain Baseline, 8, 16, and 24 weeks Patient's rating of "worst pain" experienced between prestudy and week 24. Changes of \>=2 points on the Brief Pain Inventory (BPI) are of interest. Pain is self-reported on the Brief Pain Inventory Short Form, on a 0-10 response scale, with higher scores reflecting more pain and more interference with functioning.
MUC-1 Antigen Response at 4, 8, 16, and 24 weeks MUC-1 Complete Response is reduction in MUC-1 such that MUC-1 \<= ULN. MUC-1 Partial Response is greater than or equal to a 50% reduction in MUC-1 from baseline, but not qualifying as a CR. MUC-1 Progression is greater than or equal to a 50% increase in MUC-1 from baseline. MUC-1 Stable Disease is MUC-1 response not qualifying as CR, PR, or Progression.
Change in Serum Bone Turnover Markers Over Time at baseline, 4, and 8 weeks Analysis included mean values of the serum biomarkers sRANKL, IL-6, DKK, VEGF at baseline, 4, and 8 weeks.
Change in Serum Bone Turnover Markers Over Time -- TRAP at baseline, 4, and 8 weeks Analysis included mean values of the serum biomarker TRAP at baseline, 4, and 8 weeks.
Trial Locations
- Locations (116)
Hurley Medical Center
🇺🇸Flint, Michigan, United States
University of Mississippi Cancer Clinic
🇺🇸Jackson, Mississippi, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Guardian Oncology and Center for Wellness
🇺🇸Missoula, Montana, United States
McDowell Cancer Center at Akron General Medical Center
🇺🇸Akron, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Upstate Carolina
🇺🇸Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
🇺🇸Spartanburg, South Carolina, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Valley Care Medical Center
🇺🇸Pleasanton, California, United States
St. Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Tom K Lee, Incorporated
🇺🇸Oakland, California, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Pearlman Comprehensive Cancer Center at South Georgia Medical Center
🇺🇸Valdosta, Georgia, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Valley Medical Oncology Consultants - Pleasanton
🇺🇸Pleasanton, California, United States
Larry G Strieff MD Medical Corporation
🇺🇸Oakland, California, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Foote Memorial Hospital
🇺🇸Jackson, Michigan, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
AnMed Cancer Center
🇺🇸Anderson, South Carolina, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Southwest Virginia Regional Cancer Center at Wellmonth Health
🇺🇸Norton, Virginia, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Providence Cancer Center at Providence Hospital
🇺🇸Mobile, Alabama, United States
Highlands Oncology Group - Springdale
🇺🇸Bentonville, Arkansas, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸Marysville, California, United States
El Camino Hospital Cancer Center
🇺🇸Mountain View, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Lovelace Medical Center - Downtown
🇺🇸Albuquerque, New Mexico, United States
Interlakes Oncology/Hematology PC
🇺🇸Rochester, New York, United States
Rutherford Hospital
🇺🇸Rutherfordton, North Carolina, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
🇺🇸Martinsville, Virginia, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
St. Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
🇺🇸Port Huron, Michigan, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Providence Cancer Center
🇺🇸Anchorage, Alaska, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
🇺🇸Saginaw, Michigan, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Salem Hospital Regional Cancer Care Services
🇺🇸Salem, Oregon, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Cancer Care Center of Decatur
🇺🇸Decatur, Illinois, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Genesis Medical Center - West Campus
🇺🇸Davenport, Iowa, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Grant Medical Center Cancer Care
🇺🇸Columbus, Ohio, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Mount Carmel St. Ann's Cancer Center
🇺🇸Westerville, Ohio, United States
Franciscan Cancer Center at St. Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Saint Joseph Mercy Cancer Center
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Hematology Oncology Associates, PC
🇺🇸Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Crossroads Cancer Center
🇺🇸Effingham, Illinois, United States