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Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

NCT ID: NCT00334295

Last Updated: 2012-07-31

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to determine the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.

Detailed Description

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Conditions

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Endometrial Carcinoma

Keywords

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Recurrent or metastatic endometrial carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fulvestrant

A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed, recurrent or metastatic endometrial carcinoma
* Postmenopausal
* Hormonreceptor positive

Exclusion Criteria

* Pre-treatment with Fulvestrant
* Previous endocrine therapy of the endometrial carcinoma
* Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin
Minimum Eligible Age

18 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 Germany Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Erlangen, , Germany

Site Status

Research Site

Göttingen, , Germany

Site Status

Research Site

Halle, , Germany

Site Status

Research Site

Jena, , Germany

Site Status

Research Site

Lübeck, , Germany

Site Status

Research Site

Mainz, , Germany

Site Status

Research Site

Münster, , Germany

Site Status

Research Site

Neunkirchen, , Germany

Site Status

Research Site

Rostock, , Germany

Site Status

Countries

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Germany

Other Identifiers

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9238GR/0002

Identifier Type: -

Identifier Source: org_study_id