Clinical trial NCT00093002: Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-09-29
Enrollment: 179
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Anti-proliferative effect after 4 weeks of treatment.
Secondary outcomes:
measure: Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Winchester
country: United States
facility: Research Site
state: Massachusetts
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Laredo
country: United States
facility: Research Site
state: Texas
city: Innsbruck
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Barretos
country: Brazil
facility: Research Site
city: Florianopolis
country: Brazil
facility: Research Site
city: Goiamia
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Santo Andre
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Hyderabaad
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Trivandrum
country: India
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Faslodex Medical Science Director, MD
role: STUDY_DIRECTOR
References: