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

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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00093002

Enrollment

179

Registered

2004-09-29

Start date

2004-06-30

Completion date

2007-07-31

Last updated

2008-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGFulvestrant

250 mg & 500 mg intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Anti-proliferative effect after 4 weeks of treatment.	—

Secondary

Measure	Time frame
Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.	—

Countries

Austria, Brazil, Germany, India, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026