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

NCT ID: NCT00313170

Last Updated: 2020-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-30

Study Completion Date

2019-03-13

Brief Summary

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This study will assess the relationship between fulvestrant dose and efficacy in 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 250 mg)

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

intramuscular injection 250 mg \& 500 mg

2

Fulvestrant 250 mg (+ 250 mg loading regimen)

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

intramuscular injection 250 mg \& 500 mg

3

Fulvestrant 500 mg (intramuscular injection 500 mg)

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

intramuscular injection 250 mg \& 500 mg

Interventions

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Fulvestrant

intramuscular injection 250 mg \& 500 mg

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 (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 BC.
* Treatment with more than one previous regimen of endocrine therapy for advanced BC.
* An existing condition that prevents compliance.
Minimum Eligible Age

45 Years

Maximum Eligible Age

130 Years

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 Breast Cancer Established Brands Team Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Brussels, , Belgium

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Leuven, , Belgium

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Roeselare, , Belgium

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Wilrijk, , Belgium

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Cambridge, Ontario, Canada

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London, Ontario, Canada

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Oshawa, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Cheb, , Czechia

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Jičín, , Czechia

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Prague, , Czechia

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Bordeaux, , France

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Brivé, , France

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Clermont-Ferrand, , France

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Poitiers, , France

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Szeged, , Hungary

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Tatabánya, , Hungary

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Bydgoszcz, , Poland

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Gdansk, , Poland

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Gdansk, , Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Istanbul, , Turkey (Türkiye)

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Countries

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Belgium Canada Czechia France Hungary Poland Romania Turkey (Türkiye)

References

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Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15.

Reference Type DERIVED
PMID: 20632084 (View on PubMed)

Other Identifiers

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FINDER II

Identifier Type: -

Identifier Source: secondary_id

D6997C00006

Identifier Type: -

Identifier Source: org_study_id

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