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. (CONFIRM)

AstraZeneca

Status and phase

Active, not recruiting

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00099437

2004-002371-16 (EudraCT Number)

D6997C00002

Details and patient eligibility

About

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.

Enrollment

736 patients

Sex

Female

Ages

45 to 130 years old

Volunteers

No Healthy Volunteers

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