Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy - Full Text View

Purpose

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: Fulvestrant Drug: Anastrozole	Phase III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Anastrozole Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to progression

Secondary Outcome Measures:

Objective tumour response
clinical benefit, safety

Estimated Enrollment:	512
Study Start Date:	January 2004
Estimated Study Completion Date:	June 2009

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

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or PgR positive breast cancer, local recurrence or metastasis

Exclusion Criteria:

Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy
Premenopausal women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256698

Show 85 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Roger Henriksson, MD	AstraZeneca

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	D6997L00002, 9238SW/0001, FACT
First Received:	November 20, 2005
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00256698
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Hormone

receptor

positive

breast

cancer

first

relapse

Study placed in the following topic categories:

Anastrozole

Skin Diseases

Fulvestrant

Breast Neoplasms

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 September 19, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00256698