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 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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Hormones

Drug Information available for: Exemestane Fulvestrant

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 ]

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


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

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:

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

Faslodex Information This link exits the ClinicalTrials.gov site

CSR-9238IL-0048.pdf This link exits the ClinicalTrials.gov site


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:	February 23, 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

ClinicalTrials.gov processed this record on August 23, 2017

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