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Trial to Evaluate the Therapeutic Benefit of Fulvestrant in Combination With ZACTIMA in Postmenopausal Women With Bone Predominant, Hormone Receptor Positive Metastatic Breast Cancer

NCT00811369 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2013-11-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether the combination of fulvestrant and ZACTIMA, versus fulvestrant plus placebo, results in a significant decrease in the bone marker, urinary N-Telopeptide (NTx) in postmenopausal women with bone only, or bone predominant, hormone receptor-positive metastatic breast cancer. A significant decrease will be defined as a \> 30% reduction in urinary NTx level from baseline.

Conditions

Interventions

DRUG

Fulvestrant + ZACTIMA

ZACTIMA 100 mg tablets. Dose = 1 tablet daily until disease progression or intolerance

DRUG

Fulvestrant + Placebo

ZACTIMA Placebo 100 mg tablets. Dose = 1 tablet daily for duration of study.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Ontario Clinical Oncology Group (OCOG)

    lead OTHER

Principal Investigators

  • Mark Clemons, MD · The Ottawa Hospital Regional Cancer Centre

  • Rebecca Dent, MD · Odette Cancer Centre - Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-10-31
Completion
2013-08-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811369 on ClinicalTrials.gov