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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Breast Cancer	Drug: Fulvestrant	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	179 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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).
Study Start Date :	June 2004
Actual Study Completion Date :	July 2007

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; 250 mg fulvestrant	Drug: Fulvestrant; 250 mg & 500 mg intramuscular injection; Other Names: FASLODEX™; ZD9238
Experimental: 2; 500 mg fulvestrant	Drug: Fulvestrant; 250 mg & 500 mg intramuscular injection; Other Names: FASLODEX™; ZD9238

Outcome Measures

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Primary Outcome Measures :

1. Anti-proliferative effect after 4 weeks of treatment.

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes 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

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  Show 32 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	AstraZeneca Faslodex Medical Science Director, MD	AstraZeneca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Medline Plus - Information on Breast Cancer 

Breastcancer.org 

Cancerguide.org - Pros and Cons of Researching Your Cancer 

Faslodex Information 

ClinicalTrials.gov Identifier:	NCT00093002 History of Changes
Other Study ID Numbers:	9238IL/0065; D6997C00003
First Posted:	September 29, 2004
Last Update Posted:	June 12, 2008
Last Verified:	June 2008

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:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Estrogens; Estradiol; Fulvestrant	Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Estrogen Receptor Antagonists; Estrogen Antagonists; Hormone Antagonists