Trial · NCT00371254
A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer
NCT00371254, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2011-03-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer. Trials, record NCT00371254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00371254
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer
- NCT number
- NCT00371254
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Breast Cancer, Metastasis
- Interventions
- Dasatinib, Dasatinib
- First posted
- 2006-09-04
- Last updated
- 2011-03-15
- Results first posted
- 2011-03-15
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 65 weeks). | Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD. |
| Primary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 65 weeks). | The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD. |
| Secondary | Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Baseline to 16 weeks. | The number of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: \>=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or \>=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. |
| Secondary | Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Baseline to 16 weeks | The percentage of participants whose best response was CR, PR or SD (per the RECIST) at or after 16 weeks on study: CR: disappearance of all target/non-target lesions; PR: \>=30% decrease in the sum of the LDs of target lesions relative to baseline sum LD; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; PD: appearance of new lesion/s, or \>=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions. |
| Secondary | Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 | Weeks 9, 17, and 25 | PFS:time from first dose until the date that progressive disease (PD) or clinical PD (cPD) observed,per RECIST criteria.PD:appearance of new lesion/s,or \>=20% increase in the sum of the LD of target lesions,relative to smallest sum LD recorded since treatment start,or unequivocal progression of existing non-target lesions;cPD:deterioration related to disease requiring treatment discontinuation,but without radiographic PD.Participants who died without PD were considered to have PD on the date of death.For participants who neither progressed nor died,date of the last tumor assessment was used. |
| Secondary | Mean Number of Weeks of Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 53.86 weeks) | Mean number of weeks of CR/PR (time from first date of CR/PR until first date PD observed. Tumor response defined per RECIST: CR: disappearance of all target/non-target lesions; PR: \>=30% decrease in sum of LDs of target lesions relative to baseline sum LD; PD: appearance of new lesion or \>=20% increase in sum of LD of target lesions relative to smallest sum LD or unequivocal progression of existing non-target lesions. Participants who died without reported PD were considered to have PD on date of death. For participants who neither progressed nor died, date of last tumor assessment used. |
| Secondary | Mean Plasma Concentration at Week 3 | At pre-dose and 1, 3, 6 and 12 hours after each dose administration | Mean plasma concentration was obtained directly from the concentration-time data. |
| Secondary | Mean Plasma Concentration at Week 7 | At pre-dose and 1, 3, 6 and 12 hours after each dose administration | Mean plasma concentration was obtained directly from the concentration-time data. |
| Secondary | Mean Change in Concentration of Collagen Type IV From Baseline | Baseline, Week 3 and Week 5 | Collagen Type IV is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of Collagen Type IV were obtained and analyzed by enzyme-linked immunosorbent assay. |
| Secondary | Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline | Baseline, Week 3 and Week 5 | VEGFR2 is a measure of anti-angiogenic activity. Plasma samples for assessment of change in concentration of VEGFR2 were obtained and analyzed by enzyme-linked immunosorbent assay. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 65 weeks). | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Baseline to 16 weeks. | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Baseline to 16 weeks | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, had at least 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 | Weeks 9, 17, and 25 | All treated participants | Proportion of Participants | NUMBER |
| SECONDARY | Mean Number of Weeks of Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 53.86 weeks) | Response-evaluable participants who achieved a complete response (CR) or partial response (PR) | weeks | MEAN |
| SECONDARY | Mean Plasma Concentration at Week 3 | At pre-dose and 1, 3, 6 and 12 hours after each dose administration | Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point. | nanograms (ng)/mL | MEAN |
| PRIMARY | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | Baseline to end of study drug therapy (up to 65 weeks). | All response-evaluable participants i.e. all treated participants who had at least 1 measurable lesion at baseline, 1 on-study tumor assessment or discontinued before any on-study tumor assessment for reasons related to disease or study drug were included in this dataset. | percentage of participants | NUMBER |
| SECONDARY | Mean Plasma Concentration at Week 7 | At pre-dose and 1, 3, 6 and 12 hours after each dose administration | Participants who were evaluable for pharmacokinetic analysis. n signifies the number of participants evaluable at each time point. | nanograms (ng)/mL | MEAN |
| SECONDARY | Mean Change in Concentration of Collagen Type IV From Baseline | Baseline, Week 3 and Week 5 | Participants who were evaluable for pharmacodynamic analysis. | percentage of baseline | GEOMETRIC_MEAN |
| SECONDARY | Mean Change in Concentration of Vascular Endothelial Growth Factor Receptor-2 (VEGFR2) From Baseline | Baseline, Week 3 and Week 5 | Participants who were evaluable for pharmacodynamic analysis. | percentage of baseline | GEOMETRIC_MEAN |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Complete Response (CR) or Partial Response (PR) | Dasatinib 100 mg BID | 2 | participants | ||
| Number of Participants With Complete Response (CR) or Partial Response (PR) | Dasatinib 70 mg BID | 0 | participants | ||
| Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Dasatinib 100 mg BID | 3 | Participants | ||
| Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Dasatinib 70 mg BID | 1 | Participants | ||
| Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Dasatinib 100 mg BID | 13.04 | 95% Confidence Interval 2.78 to 33.59 | percentage of participants | |
| Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Dasatinib 70 mg BID | 5.0 | 95% Confidence Interval 0.13 to 24.87 | percentage of participants | |
| Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 | Dasatinib 100 mg BID | Week 9 | 0.40 | 0.13 | Proportion of Participants |
| Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 | Dasatinib 70 mg BID | Week 9 | 0.35 | 0.12 | Proportion of Participants |
| Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 | Dasatinib 100 mg BID | Week 17 | 0.32 | 0.13 | Proportion of Participants |
| Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25 | Dasatinib 70 mg BID | Week 17 | 0.14 | 0.09 | Proportion of Participants |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib 100 mg BID | 23 | |
| Overall Study | STARTED | Dasatinib 70 mg BID | 21 | |
| Overall Study | COMPLETED | Dasatinib 100 mg BID | 0 | |
| Overall Study | COMPLETED | Dasatinib 70 mg BID | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib 100 mg BID | 23 | |
| Overall Study | NOT COMPLETED | Dasatinib 70 mg BID | 21 |
Source ClinicalTrials.gov
Adverse events67
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 | DRY EYE | Eye disorders | All Participants | 3 | 44 | |
| other | WEIGHT DECREASED | Investigations | All Participants | 5 | 44 | |
| other | ALANINE AMINOTRANSFERASE | Investigations | All Participants | 4 | 44 | |
| other | ASPARTATE AMINOTRANSFERASE | Investigations | All Participants | 4 | 44 | |
| other | ELECTROCARDIOGRAM QT PROLONGED | Investigations | All Participants | 3 | 44 | |
| other | FLUSHING | Vascular disorders | All Participants | 4 | 44 | |
| other | HOT FLUSH | Vascular disorders | All Participants | 5 | 44 | |
| other | ANXIETY | Psychiatric disorders | All Participants | 5 | 44 | |
| other | INSOMNIA | Psychiatric disorders | All Participants | 7 | 44 | |
| other | HEADACHE | Nervous system disorders | All Participants | 15 | 44 |
1 to 10 of 67Source ClinicalTrials.gov
See all 67 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 44 | 44 |
| Total, serious adverse events | All Participants | 14 | 44 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dasatinib 100 mg BID vs Dasatinib 70 mg BID: Number of Participants With Identified Electrocardiogram (ECG) Abnormalities | Trial comparisons |
| Dasatinib 100 mg BID vs Dasatinib 70 mg BID: Number of Participants With Complete Response (CR) or Partial Response (PR) | Trial comparisons |
| Dasatinib 100 mg BID vs Dasatinib 70 mg BID: Number of Participants With Abnormal Vital Signs Measurements | Trial comparisons |
| Dasatinib 100 mg BID vs Dasatinib 70 mg BID: Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study | Trial comparisons |
| Dasatinib 100 mg BID vs Dasatinib 70 mg BID: Number of Participants With Abnormalities (Grade 1 or 2) in Partial Thromboplastin Time (PTT) | 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/NCT00371254
GET https://conductscience.org/api/trials/v1/NCT00371254/registered?page=2