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Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

NCT ID: NCT00328120

Last Updated: 2010-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2010-06-30

Brief Summary

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The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer

Detailed Description

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Conditions

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Advanced Breast Cancer

Keywords

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Advanced breast cancer Faslodex

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

500 mg intramuscular injection

Intervention Type DRUG

Other Intervention Names

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Faslodex ZD9238

Eligibility Criteria

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Inclusion Criteria

* Provision of written informed consent
* Postmenopausal woman who fulfils any one of the following criteria:
* Histological or cytological confirmation of breast cancer
* Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).

Exclusion Criteria

* Having received any one of the following therapy for advanced or recurrent breast cancer
* 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Breast Cancer Established Brands Team Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Chiba, , Japan

Site Status

Research Site

Fukuoka, , Japan

Site Status

Research Site

Nagoyata, , Japan

Site Status

Research Site

Osaka, , Japan

Site Status

Research Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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9238IL/0062

Identifier Type: -

Identifier Source: secondary_id

D6995C00004

Identifier Type: -

Identifier Source: org_study_id