Trial · NCT00371345
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
NCT00371345, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2010-11-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer. Trials, record NCT00371345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00371345
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
- NCT number
- NCT00371345
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Breast Cancer, Metastasis
- Interventions
- Dasatinib, Dasatinib 100 mg
- First posted
- 2006-09-04
- Last updated
- 2011-04-26
- Results first posted
- 2010-11-05
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Objective Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR. |
| Primary | Percentage of Participants With Objective Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment | Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants. |
| Primary | Best Overall Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment | Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD. |
| Secondary | Number of Response-evaluable Participants With Disease Control (DCR) | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks. |
| Secondary | Percentage of Response-evaluable Participants With Disease Control (DCR) | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks. |
| Secondary | Number of Participants Who Progressed | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed. |
| Secondary | Median Progression Free Survival (PFS) | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed. |
| Secondary | Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25 | At Weeks 9, 17, and 25 | PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed. |
| Secondary | Duration Of Objective Response | the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed | Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment. |
| Secondary | Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
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 Objective Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment. One participant was not evaluable (no on-study tumor assessment for other reason). | participants | NUMBER |
| PRIMARY | Percentage of Participants With Objective Response | From day of first treatment through Week 25 or at time of discontinuation from study treatment | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | percentage of participants | NUMBER |
| SECONDARY | Number of Response-evaluable Participants With Disease Control (DCR) | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | participants | NUMBER |
| SECONDARY | Percentage of Response-evaluable Participants With Disease Control (DCR) | From day of first treatment through Week 25 or at time of discontinuation from study treatment. | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | percentage of participants | MEAN |
| SECONDARY | Number of Participants Who Progressed | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks. | participants | NUMBER |
| SECONDARY | Median Progression Free Survival (PFS) | From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45) | All-Treated subjects: All subjects who received at least one dose of dasatinib. The longest on-study observation for a participant was 45 weeks. | weeks | MEDIAN |
| SECONDARY | Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25 | At Weeks 9, 17, and 25 | Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment). | percentage of participants | NUMBER |
| SECONDARY | Duration Of Objective Response | the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed | Of 69 response-evaluable participants, three had an objective response of PR. | weeks | NUMBER |
| SECONDARY | Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | All-Treated participants: All participants who received at least one dose of dasatinib. | participants | NUMBER |
| SECONDARY | Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities | Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug | All-Treated participants: All participants who received at least one dose of dasatinib. | participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group186
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 Objective Response | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | 0 | participants | ||
| Number of Participants With Objective Response | Her2/Neu-amplified Tumor, 100 mg BID | 1 | participants | ||
| Number of Participants With Objective Response | ER and/or PgR Positive Tumor, 70 mg BID Dasatinib | 1 | participants | ||
| Number of Participants With Objective Response | ER and/or PgR Positive Tumor, 100 mg BID Dasatinib | 1 | participants | ||
| Percentage of Participants With Objective Response | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | 0 | 95% Confidence Interval 0 to 0 | percentage of participants | |
| Percentage of Participants With Objective Response | Her2/Neu-amplified Tumor, 100 mg BID Dasatinib | 11.11 | 95% Confidence Interval 0.28 to 48.25 | percentage of participants | |
| Percentage of Participants With Objective Response | ER and/or PgR Positive Tumor, 70 mg BID Dasatinib | 3.23 | 95% Confidence Interval 0.08 to 16.70 | percentage of participants | |
| Percentage of Participants With Objective Response | ER and/or PgR Positive Tumor, 100 mg BID Dasatinib | 7.14 | 95% Confidence Interval 0.18 to 33.87 | percentage of participants | |
| Percentage of Participants With Objective Response | All Response-evaluable Participants | 4.35 | 95% Confidence Interval 0.91 to 12.18 | percentage of participants | |
| Number of Response-evaluable Participants With Disease Control (DCR) | Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib | Participants with CR | 0 | participants |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Her2/Neu-amplified Tumor Type | 24 | |
| Overall Study | STARTED | ER and/or PgR Positive Tumor Type | 46 | |
| Overall Study | COMPLETED | Her2/Neu-amplified Tumor Type | 0 | |
| Overall Study | COMPLETED | ER and/or PgR Positive Tumor Type | 0 | |
| Overall Study | NOT COMPLETED | Her2/Neu-amplified Tumor Type | 24 | |
| Overall Study | NOT COMPLETED | ER and/or PgR Positive Tumor Type | 46 |
Source ClinicalTrials.gov
Adverse events66
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 | LACRIMATION INCREASED | Eye disorders | Dasatinib | 4 | 70 | |
| other | WEIGHT DECREASED | Investigations | Dasatinib | 8 | 70 | |
| other | HAEMOGLOBIN DECREASED | Investigations | Dasatinib | 4 | 70 | |
| other | ALANINE AMINOTRANSFERASE | Investigations | Dasatinib | 5 | 70 | |
| other | ASPARTATE AMINOTRANSFERASE | Investigations | Dasatinib | 4 | 70 | |
| other | ALANINE AMINOTRANSFERASE INCREASED | Investigations | Dasatinib | 10 | 70 | |
| other | ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | Dasatinib | 12 | 70 | |
| other | BLOOD ALKALINE PHOSPHATASE INCREASED | Investigations | Dasatinib | 6 | 70 | |
| other | PERICARDIAL EFFUSION | Cardiac disorders | Dasatinib | 7 | 70 | |
| other | INSOMNIA | Psychiatric disorders | Dasatinib | 4 | 70 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 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 | 65 | 70 |
| Total, serious adverse events | Dasatinib | 20 | 70 |
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/NCT00371345
GET https://conductscience.org/api/trials/v1/NCT00371345/results?page=2