Trial · NCT00903006
Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer
NCT00903006, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2015-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer. Trials, record NCT00903006. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00903006
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer
- NCT number
- NCT00903006
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 11 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Breast Cancer
- Interventions
- Fulvestrant, MK-0646, Dasatinib
- First posted
- 2009-05-15
- Last updated
- 2015-02-02
- Results first posted
- 2015-02-02
- Limitations and caveats
- Study terminated early due to small sample size.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase I Maximum Tolerated Dose (MTD) for Dose Level 1 | 28 day cycle | Maximum Tolerated Dose (MTD) defined as the dose or dose-combination that has the mean posterior toxicity rate closest to the target toxicity rate of 0.33. Dose levels reviewed with each 28 day cycle. Treatment dose levels: Fulvestrant will be given using a loading dose of 500 mg intramuscularly (IM) on day 1 as two 250 mg/5 ml injections, followed by 500 mg IM on day 15 and on day 1 of each subsequent 28- day (+/- 2 days) cycle. MK-0646 will be given intravenously on days 1,8, 15, and 22 for each cycle at one of the two dose levels: 1) 5 mg/kg or 2) 10 mg/kg (Dose level 1) Dasatinib will be given orally (PO) continuously on days 1 -28 for each cycle at one of two dose levels: 1) 70 mg po daily or 2) 100 mg po daily |
| Primary | Patient Response (+ Time to Disease Progression) | Baseline, after two 28 day cycles, until disease progression. |
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 | Phase I Maximum Tolerated Dose (MTD) for Dose Level 1 | 28 day cycle | Study terminated early; Analysis not available due to smaller sample size. | ||
| PRIMARY | Patient Response (+ Time to Disease Progression) | Baseline, after two 28 day cycles, until disease progression. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Fulvestrant | 2 | |
| Overall Study | STARTED | Group 2: Fulvestrant + Dasatinib | 3 | |
| Overall Study | STARTED | Group 3: Fulvestrant + MK-0646 | 1 | |
| Overall Study | STARTED | Group 4: Fulvestrant, MK-0646 + Dasatinib | 0 | |
| Overall Study | COMPLETED | Group 1: Fulvestrant | 0 | |
| Overall Study | COMPLETED | Group 2: Fulvestrant + Dasatinib | 0 | |
| Overall Study | COMPLETED | Group 3: Fulvestrant + MK-0646 | 0 | |
| Overall Study | COMPLETED | Group 4: Fulvestrant, MK-0646 + Dasatinib | 0 | |
| Overall Study | NOT COMPLETED | Group 1: Fulvestrant | 2 | |
| Overall Study | NOT COMPLETED | Group 2: Fulvestrant + Dasatinib | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events272
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 | Alanine aminotransferase increased | Metabolism and nutrition disorders | Group 1: Fulvestrant | 1 | 2 | 1 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Group 2: Fulvestrant + Dasatinib | 0 | 3 | 0 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Group 3: Fulvestrant + MK-0646 | 0 | 1 | 0 |
| other | Alanine aminotransferase increased | Metabolism and nutrition disorders | Group 4: Fulvestrant, MK-0646 + Dasatinib | 0 | 0 | 0 |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | Group 1: Fulvestrant | 0 | 2 | 0 |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | Group 2: Fulvestrant + Dasatinib | 2 | 3 | 3 |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | Group 3: Fulvestrant + MK-0646 | 0 | 1 | 0 |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | Group 4: Fulvestrant, MK-0646 + Dasatinib | 0 | 0 | 0 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Group 1: Fulvestrant | 1 | 2 | 1 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Group 2: Fulvestrant + Dasatinib | 0 | 3 | 0 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Fulvestrant | ||
| Total, all-cause mortality | Group 2: Fulvestrant + Dasatinib | ||
| Total, all-cause mortality | Group 3: Fulvestrant + MK-0646 | ||
| Total, all-cause mortality | Group 4: Fulvestrant, MK-0646 + Dasatinib | ||
| Total, other adverse events | Group 1: Fulvestrant | 2 | 2 |
| Total, other adverse events | Group 2: Fulvestrant + Dasatinib | 3 | 3 |
| Total, other adverse events | Group 3: Fulvestrant + MK-0646 | 1 | 1 |
| Total, other adverse events | Group 4: Fulvestrant, MK-0646 + Dasatinib | 0 | 0 |
| Total, serious adverse events | Group 1: Fulvestrant | 1 | 2 |
| Total, serious adverse events | Group 2: Fulvestrant + Dasatinib | 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT00903006
GET https://conductscience.org/api/trials/v1/NCT00903006/events?page=2