Trial · NCT00410813
S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone
NCT00410813, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2017-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone. Trials, record NCT00410813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00410813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0622, Dasatinib in Treating Patients With Stage IV Breast Cancer That Has Spread to the Bone
- NCT number
- NCT00410813
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 85 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Breast Cancer, Metastatic Cancer
- Interventions
- dasatinib
- First posted
- 2006-12-13
- Last updated
- 2017-07-02
- Results first posted
- 2017-07-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | Up to 2 years | All eligible patients were included in this analysis. | weeks | MEDIAN |
| SECONDARY | Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Up to 2 years | All eligible patients | participants | NUMBER |
| SECONDARY | MUC-1 Antigen Response | at 4, 8, 16, and 24 weeks | MUC-1 Inadequate Assessment, response unknown: MUC-1 response has not been adequately assessed at indicated timepoints. | ||
| SECONDARY | Circulating Tumor Cells (CTC) Response Rate | Up to 4 weeks | Treatment arms are combined in this analysis. Only eligible patients evaluated at both baseline and at 4 weeks were included. Patients analyzed for CTC response only includes patients who had elevated CTCs at baseline. | participants | NUMBER |
| SECONDARY | Change in Serum Bone Turnover Markers Over Time -- NTx | at baseline, 4, and 8 weeks | Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52. | nM BCE | MEAN |
| SECONDARY | Change in Serum Bone Turnover Markers Over Time -- BAP | at baseline, 4, and 8 weeks | Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52. | ug/L | MEAN |
| SECONDARY | Change in Serum Bone Turnover Markers Over Time | at baseline, 4, and 8 weeks | Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52. | pg/mL | MEAN |
| SECONDARY | Change in Serum Bone Turnover Markers Over Time -- OC | at baseline, 4, and 8 weeks | Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52. | ng/mL | MEAN |
| SECONDARY | Change in Serum Bone Turnover Markers Over Time -- OPG | at baseline, 4, and 8 weeks | Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52. | pmol/L | MEAN |
| SECONDARY | Change in Serum Bone Turnover Markers Over Time -- TRAP | at baseline, 4, and 8 weeks | Number of patients with samples to analyze: baseline n=66, 4 weeks n=54, 8 weeks n=52. | U/L | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Dasatinib, 100 mg, Daily | 10.3 | 95% Confidence Interval 8.4 to 16.7 | weeks | |
| Progression-free Survival | Dasatinib, 70 mg, Twice Daily | 15.3 | 95% Confidence Interval 8.7 to 20.1 | weeks | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 100 mg, Daily | Partial Response | 1 | participants | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 70 mg, Twice Daily | Partial Response | 0 | participants | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 100 mg, Daily | Stable/No Response | 14 | participants | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 70 mg, Twice Daily | Stable/No Response | 18 | participants | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 100 mg, Daily | Increasing Disease | 20 | participants | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 70 mg, Twice Daily | Increasing Disease | 10 | participants | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 100 mg, Daily | Assessment Inadequate | 6 | participants | |
| Response Rate (Complete and Partial, Confirmed and Unconfirmed) | Dasatinib, 70 mg, Twice Daily | Assessment Inadequate | 10 | participants |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib, 100 mg, Daily | 43 | |
| Overall Study | STARTED | Dasatinib, 70 mg, Twice Daily | 42 | |
| Overall Study | Eligible | Dasatinib, 100 mg, Daily | 41 | |
| Overall Study | Eligible | Dasatinib, 70 mg, Twice Daily | 38 | |
| Overall Study | COMPLETED | Dasatinib, 100 mg, Daily | 0 | |
| Overall Study | COMPLETED | Dasatinib, 70 mg, Twice Daily | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib, 100 mg, Daily | 43 | |
| Overall Study | NOT COMPLETED | Dasatinib, 70 mg, Twice Daily | 42 |
Source ClinicalTrials.gov
Adverse events154
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemoglobin | Blood and lymphatic system disorders | Dasatinib, 100 mg, Daily | 16 | 41 | |
| other | Hemoglobin | Blood and lymphatic system disorders | Dasatinib, 70 mg, Twice Daily | 22 | 38 | |
| other | Constipation | Gastrointestinal disorders | Dasatinib, 100 mg, Daily | 8 | 41 | |
| other | Constipation | Gastrointestinal disorders | Dasatinib, 70 mg, Twice Daily | 3 | 38 | |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib, 100 mg, Daily | 10 | 41 | |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib, 70 mg, Twice Daily | 14 | 38 | |
| other | Dysphagia (difficulty swallowing) | Gastrointestinal disorders | Dasatinib, 100 mg, Daily | 1 | 41 | |
| other | Dysphagia (difficulty swallowing) | Gastrointestinal disorders | Dasatinib, 70 mg, Twice Daily | 2 | 38 | |
| other | Flatulence | Gastrointestinal disorders | Dasatinib, 100 mg, Daily | 3 | 41 | |
| other | Flatulence | Gastrointestinal disorders | Dasatinib, 70 mg, Twice Daily | 2 | 38 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib, 100 mg, Daily | ||
| Total, all-cause mortality | Dasatinib, 70 mg, Twice Daily | ||
| Total, other adverse events | Dasatinib, 100 mg, Daily | 34 | 41 |
| Total, other adverse events | Dasatinib, 70 mg, Twice Daily | 36 | 38 |
| Total, serious adverse events | Dasatinib, 100 mg, Daily | 6 | 41 |
| Total, serious adverse events | Dasatinib, 70 mg, Twice Daily | 12 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dasatinib, 100 mg, Daily vs Dasatinib, 70 mg, Twice Daily: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00410813
GET https://conductscience.org/api/trials/v1/NCT00410813/results?page=2