A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg

NCT ID: NCT00305448

Last Updated: 2012-02-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-02-29

Brief Summary

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This study will assess the relationship between fulvestrant dose and efficacy, and determine the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen receptor positive advanced breast cancer.

Detailed Description

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Conditions

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Advanced Breast Cancer Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Fulvestrant 250 mg intramuscular injection

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

250 intramuscular injection

2

Fulvestrant 250mg (Plus 250mg Loading Regimen)

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

250 intramuscular injection

3

Fulvestrant 500 mg

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

500 mg intramuscular injection

Interventions

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Fulvestrant

250 intramuscular injection

Intervention Type DRUG

Fulvestrant

500 mg intramuscular injection

Intervention Type DRUG

Other Intervention Names

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Faslodex ZD9238

Eligibility Criteria

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Inclusion Criteria

* Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
* Requiring hormonal treatment
* Postmenopausal women defined as a woman who has stopped having menstrual periods

Exclusion Criteria

* Treatment with more than one previous regimen of systemic anticancer therapy other than endocrine therapy for advanced breast cancer
* Treatment with more than one previous regimen of endocrine therapy for advanced breast cancer
* An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca Japan Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Nagoya, Aichi-ken, Japan

Site Status

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Asahi, Chiba, Japan

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Chiba, Chiba, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Daito, Fukushima, Japan

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Kōriyama, Fukushima, Japan

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Ōta, Gunma, Japan

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Fukuyama, Hiroshima, Japan

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Hiroshima, Hiroshima, Japan

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Kure, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Matsubaracho, Kagoshima-ken, Japan

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Isehara, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Kumamoto, Kumamoto, Japan

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Sendai, Miyagi, Japan

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Niigata, Niigata, Japan

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Ōita, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Izumisano, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai, Osaka, Japan

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Suita, Osaka, Japan

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Morohongō, Saitama, Japan

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Shinden, Saitama, Japan

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Shizuoka, Shizuoka, Japan

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Shimotsuke, Tochigi, Japan

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Chūō, Tokyo, Japan

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Koto-ku, Tokyo, Japan

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Research Site

Kawasaki, , Japan

Site Status

Countries

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Japan

Other Identifiers

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FINDER I

Identifier Type: -

Identifier Source: secondary_id

D6997C00004

Identifier Type: -

Identifier Source: org_study_id

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