Trial · NCT00566618
Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
NCT00566618, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2022-02-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis. Trials, record NCT00566618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00566618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib in Combination With Zoledronic Acid for the Treatment of Breast Cancer With Bone Metastasis
- NCT number
- NCT00566618
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 31 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Breast Cancer, Bone Metastases
- Interventions
- Dasatinib, Zoledronic Acid
- First posted
- 2007-12-03
- Last updated
- 2022-02-25
- Results first posted
- 2022-02-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response in Bone From Time of Initiation of Therapy to > 6 Months | 6 months | Objective response rate is defined as the clinical benefit rate (complete and partial response) + stable disease \> 6 months in bone. |
| Primary | Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid | day 1 (+/- 48 hours) prior to therapy during cycle 2 and all subsequent cycles | To determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for dasatinib in combination with zoledronic acid. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response in Bone From Time of Initiation of Therapy to > 6 Months | 6 months | ITT, intent-to-treat analysis of all patients combined. The PI, Stacy Moulder, and those affiliated with the protocol is no longer at the institution. The objective response in bone from time to initiation of therapy to \>6 months analysis are combined based on the published article. We have attempted to the best of our ability to locate the data for each phase but we were unsuccessful. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid | day 1 (+/- 48 hours) prior to therapy during cycle 2 and all subsequent cycles | mg | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response in Bone From Time of Initiation of Therapy to > 6 Months | Phase I/Phase II | Central Review | 8 | Participants | |
| Objective Response in Bone From Time of Initiation of Therapy to > 6 Months | Phase I/Phase II | Site Review | 7 | Participants | |
| Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid | Phase I | Dasatinib | 100 | mg | |
| Phase I - Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) for Dasatinib in Combination With Zoledronic Acid | Phase I | zoledronic acid | 4 | mg |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase I Dasatinib (70 mg) | 1 | |
| Overall Study | STARTED | Phase 1 Dasatinib (100 mg) | 6 | |
| Overall Study | STARTED | Phase II Drug Administration | 18 | |
| Overall Study | COMPLETED | Phase I Dasatinib (70 mg) | 0 | |
| Overall Study | COMPLETED | Phase 1 Dasatinib (100 mg) | 0 | |
| Overall Study | COMPLETED | Phase II Drug Administration | 0 | |
| Overall Study | NOT COMPLETED | Phase I Dasatinib (70 mg) | 1 | |
| Overall Study | NOT COMPLETED | Phase 1 Dasatinib (100 mg) | 6 | |
| Overall Study | NOT COMPLETED | Phase II Drug Administration | 18 |
Source ClinicalTrials.gov
Adverse events18
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 | Anemia | Blood and lymphatic system disorders | Phase I/Phase II | 3 | 25 | |
| other | Fatigue | General disorders | Phase I/Phase II | 9 | 25 | |
| other | Rash | Skin and subcutaneous tissue disorders | Phase I/Phase II | 9 | 25 | |
| other | Nausea | Gastrointestinal disorders | Phase I/Phase II | 6 | 25 | |
| other | Pain | General disorders | Phase I/Phase II | 9 | 25 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase I/Phase II | 1 | 25 | |
| other | Respiratory | Respiratory, thoracic and mediastinal disorders | Phase I/Phase II | 1 | 25 | |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Phase I/Phase II | 2 | 25 | |
| other | Vasomotor symptoms | Respiratory, thoracic and mediastinal disorders | Phase I/Phase II | 4 | 25 | |
| other | Pruritus | Skin and subcutaneous tissue disorders | Phase I/Phase II | 1 | 25 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I/Phase II | 0 | 25 |
| Total, other adverse events | Phase I/Phase II | 9 | 25 |
| Total, serious adverse events | Phase I/Phase II | 0 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40446745 | DERIVED |
Source PubMed
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/NCT00566618
GET https://conductscience.org/api/trials/v1/NCT00566618/registered