Trial · NCT01934335
Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer
NCT01934335, Phase 2, Terminated, Ronald Weigel; results first posted 2021-11-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer. Trials, record NCT01934335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01934335
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Vandetanib on Cellular Markers in Invasive Breast Cancer
- NCT number
- NCT01934335
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Ronald Weigel
- Conditions
- Invasive Breast Cancer
- Interventions
- Vandetanib, Placebo
- First posted
- 2013-09-04
- Last updated
- 2021-11-01
- Results first posted
- 2021-11-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment | 2 weeks | Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for Ki-67. |
| Secondary | Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment | 2 weeks | Pre- and post-treatment samples will be assessed by immunohistochemistry for positivity for TUNEL. |
| Other | Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment | 2 weeks | Results will be stratified by RET gene expression, a negative prognostic indicator in breast cancer, to demonstrate that RET is a marker of response. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment | 2 weeks | 10 subjects took study drug and completed surgery | percentage of positivity for Ki-67. | MEAN |
| SECONDARY | Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment | 2 weeks | 10 subjects took study drug and completed surgery | percentage of for positivity for TUNEL | MEAN |
| OTHER_PRE_SPECIFIED | Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment | 2 weeks | 6 patients that got the study drug and completed surgery by RET expression were analyzed | percent change of RET positive samples | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment | Vandetanib | 0.3 | Standard Deviation 0.08 | percentage of positivity for Ki-67. | |
| Percent Change From Baseline in Ki-67 Cells Observed 2 Weeks Post-treatment | Placebo | 2 | Standard Deviation 0.05 | percentage of positivity for Ki-67. | |
| Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment | Vandetanib | 0.48 | Standard Deviation 0.71 | percentage of for positivity for TUNEL | |
| Percent Change From Baseline in TUNEL Observed 2 Weeks Post-treatment | Placebo | 1.02 | Standard Deviation 89 | percentage of for positivity for TUNEL | |
| Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment | Vandetanib | Ki-67 | -0.3 | Standard Deviation 0.03 | percent change of RET positive samples |
| Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment | Placebo | Ki-67 | 1.0 | Standard Deviation 0.12 | percent change of RET positive samples |
| Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment | Vandetanib | TUNEL | 0.77 | Standard Deviation 0.32 | percent change of RET positive samples |
| Percent Change From Baseline in RET Expression Observed 2 Weeks Post-treatment | Placebo | TUNEL | 0.2 | Standard Deviation 0.12 | percent change of RET positive samples |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib | 7 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Vandetanib | 6 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Vandetanib | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events24
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 | Nausea | Gastrointestinal disorders | Vandetanib | 1 | 6 | 1 |
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 5 | 0 |
| other | Headache | Nervous system disorders | Vandetanib | 1 | 6 | 1 |
| other | Headache | Nervous system disorders | Placebo | 1 | 5 | 1 |
| other | Dehydration | General disorders | Vandetanib | 1 | 6 | 1 |
| other | Dehydration | General disorders | Placebo | 0 | 5 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Vandetanib | 3 | 6 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 0 | 5 | 0 |
| other | Paresthesia | Nervous system disorders | Vandetanib | 1 | 6 | 1 |
| other | Paresthesia | Nervous system disorders | Placebo | 0 | 5 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib | 0 | 6 |
| Total, all-cause mortality | Placebo | 0 | 5 |
| Total, other adverse events | Vandetanib | 5 | 6 |
| Total, other adverse events | Placebo | 1 | 5 |
| Total, serious adverse events | Vandetanib | 0 | 6 |
| Total, serious adverse events | Placebo | 0 | 5 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vandetanib vs Placebo: deaths from any cause | Trial comparisons |
| Vandetanib vs Placebo: serious adverse events | 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/NCT01934335
GET https://conductscience.org/api/trials/v1/NCT01934335/events?page=2