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A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy


Phase 3
N/A
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Randomised, Double-Blind, Parallel-group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Fulvestrant (FASLODEX™) 250 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy


Inclusion Criteria:



- Breast Cancer has continued to grow after having received treatment with an
anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor

- Requiring hormonal treatment

- Postmenopausal women defined as a woman who has stopped having menstrual periods

- Evidence of positive estrogen receptor hormone sensitivity

- Written informed consent to participate in the trial

Exclusion Criteria:

- Treatment with an investigational or non-approved drug within one month

- An existing serious disease, illness, or condition that will prevent participation or
compliance with study procedures

- A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor
oil)

- Treatment with more than one regimen of chemotherapy for advanced breast cancer

- Treatment with more than one regimen of hormonal treatment for advanced breast cancer

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP)

Outcome Description:

Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).

Outcome Time Frame:

RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)

Safety Issue:

No

Principal Investigator

Faslodex Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D6997C00002

NCT ID:

NCT00099437

Start Date:

February 2005

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Research SiteMesa, Arizona  
Research SiteAnaheim, California  
Research SiteDanbury, Connecticut  
Research SiteBoca Raton, Florida  
Research SiteArlington Heights, Illinois  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteBelleville, New Jersey  
Research SiteAbilene, Texas  
Research SiteAppleton, Wisconsin