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Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer

NCT ID: NCT00259090

Last Updated: 2012-08-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2008-10-31

Brief Summary

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To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.

Detailed Description

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Conditions

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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 Monotherapy

Group Type ACTIVE_COMPARATOR

Anastrazole

Intervention Type DRUG

oral tablet

2

Fulvestrant Monotherapy

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

500 mg intramuscular injection

3

Anastrozole + Fulvestrant

Group Type EXPERIMENTAL

Fulvestrant

Intervention Type DRUG

500 mg intramuscular injection

Anastrazole

Intervention Type DRUG

oral tablet

Interventions

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Fulvestrant

500 mg intramuscular injection

Intervention Type DRUG

Anastrazole

oral tablet

Intervention Type DRUG

Other Intervention Names

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Faslodex ZD9238 Arimidex ZD1033

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women.
* Biopsy confirmation of primary breast cancer.
* Oestrogen receptor positive tumour.
* Fit for surgery within one month.
* Written informed consent to participate in the study

Exclusion Criteria

* Previous treatment with any anti-hormonal therapy for breast cancer.
* Previous radiotherapy to the primary tumour.
* Previous chemotherapy for the primary tumour.
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 Faslodex Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Robertson JF, Dixon JM, Sibbering DM, Jahan A, Ellis IO, Channon E, Hyman-Taylor P, Nicholson RI, Gee JM. A randomized trial to assess the biological activity of short-term (pre-surgical) fulvestrant 500 mg plus anastrozole versus fulvestrant 500 mg alone or anastrozole alone on primary breast cancer. Breast Cancer Res. 2013 Mar 5;15(2):R18. doi: 10.1186/bcr3393.

Reference Type DERIVED
PMID: 23497452 (View on PubMed)

Other Identifiers

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9238IL/0057

Identifier Type: -

Identifier Source: secondary_id

D6997C00057

Identifier Type: -

Identifier Source: org_study_id