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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: August 18, 2014
Last verified: August 2014
  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:


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: September 2014
Estimated Primary Completion Date: September 2014 (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
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, see Learn About Clinical Studies.

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:
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: August 18, 2014
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Exemestane
Fulvestrant
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014