We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065325
First Posted: July 23, 2003
Last Update Posted: February 24, 2015
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
Locally Advanced Breast Cancer Metastatic Breast Cancer Drug: Fulvestrant Drug: Exemestane Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: after 580 Progression events accrued ]
  • Overall survival [ Time Frame: after 580 Progression events accrued ]
  • Duration of response [ Time Frame: after 580 Progression events accrued ]
  • Clinical Benefit [ Time Frame: after 580 Progression events accrued ]
  • Quality of Life [ Time Frame: after 580 Progression events accrued ]
  • PK [ Time Frame: each visit ]
  • Safety and tolerability. [ Time Frame: after 580 Progression events accrued ]

Enrollment: 694
Study Start Date: August 2003
Study Completion Date: September 2014
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Exemestane
Drug: Exemestane
oral capsule
Other Name: AROMASIN™
Experimental: 2
Fulvestrant
Drug: Fulvestrant
intramuscular injection
Other Names:
  • Faslodex
  • ZD9238

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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)
  Contacts and Locations
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


  Show 117 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Faslodex Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00065325     History of Changes
Other Study ID Numbers: 9238IL/0048
EFECT
D6997C00048
First Submitted: July 21, 2003
First Posted: July 23, 2003
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Exemestane
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action