Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer

This study has been completed.

First Received: September 28, 2004 Last Updated: June 11, 2008 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00093002

Purpose

The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.

Condition	Intervention	Phase
Breast Cancer	Drug: Fulvestrant	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ici 182780

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Anti-proliferative effect after 4 weeks of treatment.

Secondary Outcome Measures:

Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.

Enrollment:	179
Study Start Date:	June 2004
Study Completion Date:	July 2007

Arms	Assigned Interventions
1: Experimental 250 mg fulvestrant	Drug: Fulvestrant 250 mg & 500 mg intramuscular injection
2: Experimental 500 mg fulvestrant	Drug: Fulvestrant 250 mg & 500 mg intramuscular injection

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women defined as women who have stopped having menstrual periods
Written informed consent to participate in the trial
Biopsy confirmation of invasive breast cancer
Evidence of hormone sensitivity
Willingness to undergo biopsies

Exclusion Criteria:

Any previous treatment for breast cancer
Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
The presence of more than one primary tumor
History of hypersensitivity to castor oil
History of known bleeding disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093002

Show 32 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Faslodex Medical Science Director, MD

AstraZeneca

More Information

Additional Information:

Medline Plus - Information on Breast Cancer This link exits the ClinicalTrials.gov site

Breastcancer.org This link exits the ClinicalTrials.gov site

Cancerguide.org - Pros and Cons of Researching Your Cancer This link exits the ClinicalTrials.gov site

Faslodex Information This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	9238IL/0065, D6997C00003
Study First Received:	September 28, 2004
Last Updated:	June 11, 2008
ClinicalTrials.gov Identifier:	NCT00093002 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Early Breast Cancer
neoadjuvant therapy
hormonal treatment
newly diagnosed breast cancer
Estrogen Receptor Positive Breast Cancer

treatment naïve
neoadjuvant treatment
neoadjuvant setting
invasive breast cancer

Additional relevant MeSH terms:

Estrogen Antagonists
Estrogens
Antineoplastic Agents, Hormonal
Skin Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists

Breast Neoplasms
Hormones
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009