Trial · NCT00752986
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
NCT00752986, Phase 2, Terminated, Genzyme, a Sanofi Company; results first posted 2014-10-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial. Trials, record NCT00752986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00752986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
- NCT number
- NCT00752986
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Genzyme, a Sanofi Company
- Conditions
- Breast Cancer
- Interventions
ZD6474 (Vandetanib at the dose of 100 mg), Placebo to match ZD6474 (Vandetanib at the dose of 100 mg), Fulvestrant, ZD6474 (Vandetanib at the dose of 300 mg), Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
- First posted
- 2008-09-16
- Last updated
- 2016-12-05
- Other registries' IDs
- eudract:2008-000579-12
- Results first posted
- 2014-10-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event Free Survival | Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression. | Success rate (patients without progression and still on treatment at 24 weeks |
| Secondary | Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR) | Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression. | |
| Secondary | Overall Survival | Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent. | |
| Secondary | Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes | Continuous assessment of safety. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Event Free Survival | Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression. | |||
| SECONDARY | Time-To-Progression, Progression-Free Survival, Objective Tumor Response Rate (CR+PR), Disease Control Rate (CR+PR+SD) and Duration of Response (DOR) | Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression. | |||
| SECONDARY | Overall Survival | Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent. | |||
| SECONDARY | Incidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) Changes | Continuous assessment of safety. |
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 flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vandetanib at the Dose of 100 mg | 16 | |
| Overall Study | STARTED | Vandetanib at the Dose of 300 mg | 12 | |
| Overall Study | STARTED | Placebo to Match Vandetanib 100 mg and 300 mg | 11 | |
| Overall Study | COMPLETED | Vandetanib at the Dose of 100 mg | 11 | |
| Overall Study | COMPLETED | Vandetanib at the Dose of 300 mg | 11 | |
| Overall Study | COMPLETED | Placebo to Match Vandetanib 100 mg and 300 mg | 9 | |
| Overall Study | NOT COMPLETED | Vandetanib at the Dose of 100 mg | 5 | |
| Overall Study | NOT COMPLETED | Vandetanib at the Dose of 300 mg | 1 | |
| Overall Study | NOT COMPLETED | Placebo to Match Vandetanib 100 mg and 300 mg | 2 |
Source ClinicalTrials.gov
Adverse events189
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 | RIGHT HYPOCHONDRIUM PAIN | Gastrointestinal disorders | Vandetanib at the Dose of 100 mg | 0 | 16 | 0 |
| other | RIGHT HYPOCHONDRIUM PAIN | Gastrointestinal disorders | Vandetanib at the Dose of 300 mg | 0 | 12 | 0 |
| other | RIGHT HYPOCHONDRIUM PAIN | Gastrointestinal disorders | Placebo to Match Vandetanib 100 mg and 300 mg | 1 | 11 | 1 |
| other | AST ELEVATION | Blood and lymphatic system disorders | Vandetanib at the Dose of 100 mg | 0 | 16 | 0 |
| other | AST ELEVATION | Blood and lymphatic system disorders | Vandetanib at the Dose of 300 mg | 0 | 12 | 0 |
| other | AST ELEVATION | Blood and lymphatic system disorders | Placebo to Match Vandetanib 100 mg and 300 mg | 1 | 11 | 1 |
| other | RECTAL BLEEDING | General disorders | Vandetanib at the Dose of 100 mg | 0 | 16 | 0 |
| other | RECTAL BLEEDING | General disorders | Vandetanib at the Dose of 300 mg | 0 | 12 | 0 |
| other | RECTAL BLEEDING | General disorders | Placebo to Match Vandetanib 100 mg and 300 mg | 1 | 11 | 1 |
| other | HEMORRHOIDS | General disorders | Vandetanib at the Dose of 100 mg | 0 | 16 | 0 |
1 to 10 of 189Source ClinicalTrials.gov
See all 189 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vandetanib at the Dose of 100 mg | ||
| Total, all-cause mortality | Vandetanib at the Dose of 300 mg | ||
| Total, all-cause mortality | Placebo to Match Vandetanib 100 mg and 300 mg | ||
| Total, other adverse events | Vandetanib at the Dose of 100 mg | 12 | 16 |
| Total, other adverse events | Vandetanib at the Dose of 300 mg | 11 | 12 |
| Total, other adverse events | Placebo to Match Vandetanib 100 mg and 300 mg | 6 | 11 |
| Total, serious adverse events | Vandetanib at the Dose of 100 mg | 3 | 16 |
| Total, serious adverse events | Vandetanib at the Dose of 300 mg | 2 | 12 |
| Total, serious adverse events | Placebo to Match Vandetanib 100 mg and 300 mg | 1 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 12684431 | BACKGROUND |
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/NCT00752986
GET https://conductscience.org/api/trials/v1/NCT00752986/events?page=2