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E3 Breast Cancer Taxotere Combination

A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of ZD6474 in Combination With Docetaxel (Taxotere™) vs Docetaxel Alone as 2nd Line Treatment for Advanced Breast Cancer (ABC).

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00494481
Enrollment
64
Registered
2007-06-29
Start date
2006-01-31
Completion date
2009-01-31
Last updated
2016-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer

Keywords

Zactima

Brief summary

To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology

Interventions

DRUGVandetanib (ZD6474)

once daily oral dose

DRUGDocetaxel

intravenous infusion

Sponsors

Genzyme, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Females with histological/cytological confirmation of breast cancer. * Subjects with a measurable lesion or bone lesions

Exclusion criteria

* Previous radiotherapy within 6 weeks * Significant cardiac events, arrhythmias or other cardiac conditions

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With a Disease Progression EventRECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-offNumber of patients with objective disease progression or death (by any cause in the absence of objective progression)

Countries

Hungary, South Africa, Spain, Sweden, Taiwan

Participant flow

Recruitment details

First patient randomised 03 February 2006, last patient randomised 25 April 2007, data cut off data 23 June 2007

Participants by arm

ArmCount
Vandetanib Plus Docetaxel
vandetanib 100 mg plus docetaxel
35
Placebo Plus Docetaxel
placebo plus docetaxel
29
Total64

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event1511
Overall StudyCondition under investigation worsened1113
Overall StudyNever received IP20
Overall StudyOther10

Baseline characteristics

CharacteristicVandetanib Plus DocetaxelPlacebo Plus DocetaxelTotal
Age, Continuous54 Years57 Years55.5 Years
Sex: Female, Male
Female
35 Participants29 Participants64 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
33 / 3325 / 29
serious
Total, serious adverse events
14 / 3312 / 29

Outcome results

Primary

Number of Patients With a Disease Progression Event

Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Time frame: RECIST tumour assessments carried out at screening (within 3 weeks before the 1st dose) and then as per site clinical practice until objective progression. The only additional mandatory RECIST assessment is at the point of data cut-off

ArmMeasureValue (NUMBER)
Vandetanib Plus DocetaxelNumber of Patients With a Disease Progression Event24 Participants
Placebo Plus DocetaxelNumber of Patients With a Disease Progression Event18 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026