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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryEvent Free SurvivalRestaging (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
SecondaryTime-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.
SecondaryOverall SurvivalAssessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.
SecondaryIncidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) ChangesContinuous assessment of safety.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYEvent Free SurvivalRestaging (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.
SECONDARYTime-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.
SECONDARYOverall SurvivalAssessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.
SECONDARYIncidence and Type of Adverse Events (AEs), Clinically Significant Laboratory or Vital Sign Abnormalities and Electrocardiographic (ECG) ChangesContinuous assessment of safety.

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.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDVandetanib at the Dose of 100 mg16
Overall StudySTARTEDVandetanib at the Dose of 300 mg12
Overall StudySTARTEDPlacebo to Match Vandetanib 100 mg and 300 mg11
Overall StudyCOMPLETEDVandetanib at the Dose of 100 mg11
Overall StudyCOMPLETEDVandetanib at the Dose of 300 mg11
Overall StudyCOMPLETEDPlacebo to Match Vandetanib 100 mg and 300 mg9
Overall StudyNOT COMPLETEDVandetanib at the Dose of 100 mg5
Overall StudyNOT COMPLETEDVandetanib at the Dose of 300 mg1
Overall StudyNOT COMPLETEDPlacebo to Match Vandetanib 100 mg and 300 mg2

Adverse events189

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherRIGHT HYPOCHONDRIUM PAINGastrointestinal disordersVandetanib at the Dose of 100 mg0160
otherRIGHT HYPOCHONDRIUM PAINGastrointestinal disordersVandetanib at the Dose of 300 mg0120
otherRIGHT HYPOCHONDRIUM PAINGastrointestinal disordersPlacebo to Match Vandetanib 100 mg and 300 mg1111
otherAST ELEVATIONBlood and lymphatic system disordersVandetanib at the Dose of 100 mg0160
otherAST ELEVATIONBlood and lymphatic system disordersVandetanib at the Dose of 300 mg0120
otherAST ELEVATIONBlood and lymphatic system disordersPlacebo to Match Vandetanib 100 mg and 300 mg1111
otherRECTAL BLEEDINGGeneral disordersVandetanib at the Dose of 100 mg0160
otherRECTAL BLEEDINGGeneral disordersVandetanib at the Dose of 300 mg0120
otherRECTAL BLEEDINGGeneral disordersPlacebo to Match Vandetanib 100 mg and 300 mg1111
otherHEMORRHOIDSGeneral disordersVandetanib at the Dose of 100 mg0160

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityVandetanib at the Dose of 100 mg
Total, all-cause mortalityVandetanib at the Dose of 300 mg
Total, all-cause mortalityPlacebo to Match Vandetanib 100 mg and 300 mg
Total, other adverse eventsVandetanib at the Dose of 100 mg1216
Total, other adverse eventsVandetanib at the Dose of 300 mg1112
Total, other adverse eventsPlacebo to Match Vandetanib 100 mg and 300 mg611
Total, serious adverse eventsVandetanib at the Dose of 100 mg316
Total, serious adverse eventsVandetanib at the Dose of 300 mg212
Total, serious adverse eventsPlacebo to Match Vandetanib 100 mg and 300 mg111

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
12684431BACKGROUND

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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