Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410813
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-12-11
Brief Title:
S0622 Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Studies of Two Different Schedules of Dasatinib NSC-732517 in Bone Metastasis Predominant Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S0622 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |