Trial · NCT00546104
Phase II Dasatinib Study in Advanced Breast Cancer
NCT00546104, Phase 2, Completed, Duke University; results first posted 2013-07-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Dasatinib Study in Advanced Breast Cancer. Trials, record NCT00546104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00546104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Dasatinib Study in Advanced Breast Cancer
- NCT number
- NCT00546104
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Advanced Breast Cancer
- Interventions
- Dasatinib
- First posted
- 2007-10-18
- Last updated
- 2013-07-17
- Results first posted
- 2013-07-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimation of the Proportion of Progression-free Patients at 16 Wks. | 16 weeks | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or measurable increase in a non-target lesion, or the appearance of new lesions, or similar definition as appropriate. Proportion progression-free at 16 weeks.From first day of study related treatment with Dasatinib until the date of first documented progression or date of death from any cause, whichever came first. |
| Secondary | To Measure Response to Protocol Therapy Per RECIST Criteria | 16 weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as a reference the smallest sum longest diameter recorded since treatment started, or the appearance of one or more new lesions. RECIST 1.0 Overall response: Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) CR= CR+CR and No new lesions PR= CR+SD; PR+SD and no new lesions SD= SD+SD and no new lesions PD= PD+any new lesions |
| Secondary | Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response) | 4 weeks | For the 20 patients with evaluable biopsies at baseline and week 4, the median relative change from baseline in tissue biomarker levels of phospho-Src (p-Src) |
| Secondary | Correlate SRC Dysregulation Results With Response to Dasatinib Therapy | 16 weeks | Since all patients progressed there is no comparison to between responders and non-responders. |
| Secondary | To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression. | Baseline Src measure to first progression | Spearman's correlation between the change in SRC signature from baseline to 4 weeks and time to progression |
| Secondary | To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption | not assessed | Not assessed secondary to limited number of subjects. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Estimation of the Proportion of Progression-free Patients at 16 Wks. | 16 weeks | 31 patients on this trial, 1 patient was found to have disease progression at 16-weeks, 16 patients had disease progression prior to 16 weeks, 8 patients were taken off-treatment due to toxicity, and 6 patients voluntarily withdrew from treatment. These latter two groups of patients were censored in the analysis of Progression Free Survival. | percentage of participants | NUMBER |
| SECONDARY | To Measure Response to Protocol Therapy Per RECIST Criteria | 16 weeks | Proportion with Best Response of Stable Disease | percentage of participants | NUMBER |
| SECONDARY | Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response) | 4 weeks | Twenty patients with evaluable biopsies at baseline and 4 week follow-up | percentage of change in p-SRC | MEDIAN |
| SECONDARY | Correlate SRC Dysregulation Results With Response to Dasatinib Therapy | 16 weeks | 20 patients with baseline and 4 week Src measures. 11 patients came off due to screen failure, toxicity or progression before 4 week biopsy. | percentage change in p-SRC | MEAN |
| SECONDARY | To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression. | Baseline Src measure to first progression | 11 patients had both change in Src level and progression time intervals | correlation coefficient | NUMBER |
| SECONDARY | To Explore the Association Between Dasatinib and Osteoclastic Bone Resorption | not assessed |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Estimation of the Proportion of Progression-free Patients at 16 Wks. | Dasatinib | 0 | 95% Confidence Interval 0 to 20 | percentage of participants | |
| To Measure Response to Protocol Therapy Per RECIST Criteria | Dasatinib | 16.7 | percentage of participants | ||
Characterization and Comparison of SRC (A Protein Tyrosine Kinase)Dysregulation at Baseline (All Patients), After 4 Weeks of Dasatinib Treatment (All Patients), and at Progression (Only Patients Who Progress After Documented Response) | Dasatinib | -0.125 | Inter-Quartile Range -0.41 to 0.153 | percentage of change in p-SRC | |
| Correlate SRC Dysregulation Results With Response to Dasatinib Therapy | Dasatinib | -.10 | 95% Confidence Interval -.30 to .10 | percentage change in p-SRC | |
| To Explore the Association Between Each Patient's SRC Signature and Their Time to Progression. | Dasatinib | 0.27 | correlation coefficient |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib | 31 | |
| Overall Study | COMPLETED | Dasatinib | 31 | |
| Overall Study | NOT COMPLETED | Dasatinib | 0 |
Source ClinicalTrials.gov
Adverse events49
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 | anorexia | General disorders | Dasatinib | 13 | 31 | 13 |
| other | fatigue | General disorders | Dasatinib | 16 | 31 | 16 |
| other | fever: non-neutropenic | Gastrointestinal disorders | Dasatinib | 5 | 31 | 5 |
| other | Flushing | General disorders | Dasatinib | 7 | 31 | 7 |
| other | insomnia | General disorders | Dasatinib | 8 | 31 | 8 |
| other | diarrhea | Gastrointestinal disorders | Dasatinib | 15 | 31 | 15 |
| other | constipation | Gastrointestinal disorders | Dasatinib | 11 | 31 | 11 |
| other | nausea | Gastrointestinal disorders | Dasatinib | 19 | 31 | 19 |
| other | vomiting | Gastrointestinal disorders | Dasatinib | 13 | 31 | 13 |
| other | cough | Respiratory, thoracic and mediastinal disorders | Dasatinib | 6 | 31 | 6 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib | ||
| Total, other adverse events | Dasatinib | 30 | 31 |
| Total, serious adverse events | Dasatinib | 10 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00546104
GET https://conductscience.org/api/trials/v1/NCT00546104/events?page=2