Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	45 - 127
Updated:	3/17/2019
Start Date:	February 8, 2005
End Date:	December 31, 2019

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

The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant
with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive
advanced breast cancer who have failed on a previous endocrine treatment.

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

We found this trial at

sites

Clinical Trial Facility in Brasschaat

Brasschaat,

from

Brasschaat,