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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00259090

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Fulvestrant Drug: Anastrazole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomized, Multicentre Trial to Compare the Anti-Tumour Effects and Tolerability of a 500mg Dose of Faslodex (Fulvestrant) Plus Arimidex (Anastrozole) With a 500mg Dose of Faslodex Alone and With Arimidex Alone, in Postmenopausal Women Prior to Surgery for Primary Breast Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Antitumour effects, measured by biochemical tumour markers, of Faslodex, Arimidex and a combination of both.

Secondary Outcome Measures:

Tolerability of Faslodex, Arimidex and a combination of both.

Estimated Enrollment:	120
Study Start Date:	April 2004
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Anastrozole Monotherapy	Drug: Anastrazole oral tablet
2: Experimental Fulvestrant Monotherapy	Drug: Fulvestrant 500 mg intramuscular injection
3: Experimental Anastrozole + Fulvestrant	Drug: Fulvestrant 500 mg intramuscular injection Drug: Anastrazole oral tablet

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259090

Locations

United Kingdom
Research Site
Nottingham, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Faslodex Medical Science Director, MD

AstraZeneca

More Information

Study ID Numbers:	9238IL/0057, D6997C00057
Study First Received:	November 25, 2005
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00259090
Health Authority:	United Kingdom: Department of Health

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Fulvestrant

Breast Neoplasms
Menopause
Breast Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009