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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00065325
First received: July 21, 2003
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to disease progression (TTP) [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
  • Clinical Benefit [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
  • PK [ Time Frame: each visit ] [ Designated as safety issue: No ]
  • Safety and tolerability. [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: Yes ]

Enrollment: 694
Study Start Date: August 2003
Estimated Study Completion Date: December 2012
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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065325

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

Additional Information:
MEDLINEplus related topics: Breast Cancer  This link exits the ClinicalTrials.gov site
MEDLINEplus related topics: Cancer (General)  This link exits the ClinicalTrials.gov site
MEDLINEplus related topics: Cancer--Living with Cancer  This link exits the ClinicalTrials.gov site
Cancer Guide related topics  This link exits the ClinicalTrials.gov site
Aromasin related topics: Your Treatment with Aromasin  This link exits the ClinicalTrials.gov site
Faslodex Information  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00065325     History of Changes
Other Study ID Numbers: 9238IL/0048, EFECT, D6997C00048
Study First Received: July 21, 2003
Last Updated: September 24, 2012
Health Authority: United States: Food and Drug Administration

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
Exemestane
Fulvestrant
Aromatase Inhibitors
Estradiol
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on May 16, 2013