AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2016-04-30

Brief Summary

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The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.

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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

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AZD2171

Oral tablet

Intervention Type DRUG

Fulvestrant

intramuscular injection

Intervention Type DRUG

Other Intervention Names

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Recentin Faslodex ZD9238

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Females with histological/cytological confirmation of hormone sensitive breast cancer with evidence of metastatic disease
* One or more evaluable lesions

Exclusion Criteria

* Prior hormonal therapy with fulvestrant
* More than one course of prior systemic cytotoxic chemotherapy for metastatic breast cancer
* Prior biologic therapy for ABC including Anti-VEGF agents
* Radiation therapy within 4 weeks prior to provision of consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No