The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer (EFECT)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Locally Advanced Breast Cancer

Metastatic Breast Cancer

Treatments

Drug: Exemestane

Drug: Fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00065325

EFECT

9238IL/0048

D6997C00048

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Enrollment

694 patients

Sex

Female

Ages

32 to 91 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Biopsy confirmation of Breast Cancer
Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
Postmenopausal women defined as a women who has stopped having menstrual periods
Evidence of hormone sensitivity
Written informed consent to participate in the trial

Exclusion criteria

Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
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 or Exemestane (i.e. castor oil or Mannitol)