Second Line Breast Cancer Trial - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00635713

Purpose

The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Fulvestrant Drug: Anastrozole	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Ici 182780

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

time to tumor progression [ Time Frame: Every 3 months ]

Secondary Outcome Measures:

objective tumor response [ Time Frame: Every 3 months ]
time to treatment failure [ Time Frame: Every 3 months ]
time to death [ Time Frame: Every 3 months ]

Estimated Enrollment:	588
Study Start Date:	May 1997
Study Completion Date:	September 2004

Arms	Assigned Interventions
1: Experimental Faslodex 125mg and Arimidex 1 mg	Drug: Fulvestrant 125mg Drug: Anastrozole ARIMIDEX
2: Experimental Faslodex 250mg and Arimidex 1mg	Drug: Anastrozole ARIMIDEX Drug: Fulvestrant 250mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

postmenopausal women with confirmation of breast cancer
objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

Exclusion Criteria:

presence of life-threatening metastatic visceral disease
previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
more than 1 prior endocrine medical treatment for advanced breast cancer .

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635713

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Guido Hoctin-Boes

AstraZeneca

More Information

No publications provided

Study ID Numbers:	9238IL/0021, D6995C00021
Study First Received:	March 7, 2008
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00635713 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by AstraZeneca:

Advanced breast cancer, FASLODEX, ARIMIDEX, Fulvestrant, Anastrozole, postmenopausal

Study placed in the following topic categories:

Anastrozole
Estrogens
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Fulvestrant

Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Hormones
Estrogen Receptor Modulators
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Fulvestrant

Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009