Faslodex Advanced Breast Cancer Local Chinese Study

NCT ID: NCT00327769

Last Updated: 2011-01-25

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

PHASE3

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-09-30

Brief Summary

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This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.

Detailed Description

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Conditions

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Advanced 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

Anastrozole

Group Type ACTIVE_COMPARATOR

Anastrozole

Intervention Type DRUG

1 mg tablet

2

Anastrozole + Fulvestrant

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

250 mg intramuscular injection

Anastrozole

Intervention Type DRUG

1 mg tablet

Interventions

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Fulvestrant

250 mg intramuscular injection

Intervention Type DRUG

Anastrozole

1 mg tablet

Intervention Type DRUG

Other Intervention Names

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Faslodex ZD9238 Arimidex ZD1033

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal advanced breast cancer with oestrogen receptor positive
* Progression under first-line anti-oestrogen therapy.

Exclusion Criteria

* Life-threatening metastasis; contraindication to anastrozole
* \>2 regimens of hormonotherapy for advanced breast cancer
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

Wuhan, , China

Site Status

Research Site

Xi'an, , China

Site Status

Research Site

Beijing, , China

Site Status

Research Site

Dalian, , China

Site Status

Research Site

Fuzhou, , China

Site Status

Research Site

Guangzhou, , China

Site Status

Research Site

Hankou, , China

Site Status

Research Site

Hefei, , China

Site Status

Research Site

Huangzhou, , China

Site Status

Research Site

Jinan, , China

Site Status

Research Site

Nanjing, , China

Site Status

Research Site

Shanghai, , China

Site Status

Countries

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China

References

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Xu B, Jiang Z, Shao Z, Wang J, Feng J, Song S, Chen Z, Gu K, Yu S, Zhang Y, Wang C, Zhang F, Yang J. Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial. Cancer Chemother Pharmacol. 2011 Jan;67(1):223-30. doi: 10.1007/s00280-010-1483-x. Epub 2010 Oct 12.

Reference Type DERIVED
PMID: 20938664 (View on PubMed)

Other Identifiers

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D6997L00004

Identifier Type: -

Identifier Source: org_study_id

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