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OpenTrials
Completed

NCT Number: NCT00065325

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

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.

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Key information

Conditions

Locally Advanced Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

32 year–91 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fulvestrant

Drug

intramuscular injection

Other names: Faslodex, ZD9238

Exemestane

Drug

oral capsule

Other names: AROMASIN™

Primary outcomes

  1. Time to disease progression (TTP)

    Time frame: after 580 Progression events accrued

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: EFECT

Important dates

Study start
2003
Primary completion
2006
Study completion
2014
First posted
Jul 23, 2003
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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