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

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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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

694 participants in 2 patient groups

1
Active Comparator group
Description:
Exemestane
Treatment:
Drug: Exemestane
2
Experimental group
Description:
Fulvestrant
Treatment:
Drug: Fulvestrant

Trial contacts and locations

117

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Data sourced from clinicaltrials.gov

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