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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00065325
Recruitment Status : Completed
First Posted : July 23, 2003
Last Update Posted : February 24, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Locally Advanced Breast Cancer Metastatic Breast Cancer Drug: Fulvestrant Drug: Exemestane Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 694 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy
Study Start Date : August 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: Exemestane
oral capsule
Other Name: AROMASIN™

Experimental: 2
Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238

Primary Outcome Measures :
  1. Time to disease progression (TTP) [ Time Frame: after 580 Progression events accrued ]

Secondary Outcome Measures :
  1. Objective response rate [ Time Frame: after 580 Progression events accrued ]
  2. Overall survival [ Time Frame: after 580 Progression events accrued ]
  3. Duration of response [ Time Frame: after 580 Progression events accrued ]
  4. Clinical Benefit [ Time Frame: after 580 Progression events accrued ]
  5. Quality of Life [ Time Frame: after 580 Progression events accrued ]
  6. PK [ Time Frame: each visit ]
  7. Safety and tolerability. [ Time Frame: after 580 Progression events accrued ]

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Years to 91 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065325

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Sponsors and Collaborators
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Study Director: AstraZeneca Faslodex Medical Science Director, MD AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00065325    
Other Study ID Numbers: 9238IL/0048
First Posted: July 23, 2003    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Keywords provided by AstraZeneca:
Locally advanced breast cancer
metastatic breast cancer
Breast Cancer
Cancer of Breast
Cancer of the Breast
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action