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

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 III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Ici 182780 Exemestane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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

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:	May 2003
Estimated Study Completion Date:	July 2008

Arms	Assigned Interventions
1: Active Comparator Exemestane	Drug: Exemestane oral capsule
2: Experimental Fulvestrant	Drug: Fulvestrant intramuscular injection

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 139 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Faslodex Medical Science Director, MD	AstraZeneca

More 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

Study ID Numbers:	9238IL/0048, EFECT
First Received:	July 21, 2003
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00065325
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

Study placed in the following topic categories:

Skin Diseases

Fulvestrant

Disease Progression

Breast Neoplasms

Exemestane

Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists

Antineoplastic Agents, Hormonal

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors

Pharmacologic Actions

Estrogen Receptor Modulators

Neoplasms

Neoplasms by Site

Therapeutic Uses

Aromatase Inhibitors

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00065325