Faslodex Advanced Breast Cancer Local Chinese Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00327769

Purpose

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.

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

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, Safety/Efficacy Study
Official Title:	A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-Line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to Disease Progression (TTP)

Secondary Outcome Measures:

Objective Response Rate (ORR)
Clinical Benefit Rate (CBR)
Time to Treatment Failure (TTF)
Safety & Tolerability.

Enrollment:	234
Study Start Date:	December 2005
Study Completion Date:	September 2007

Arms	Assigned Interventions
1: Active Comparator Anastrozole	Drug: Anastrozole 1 mg tablet
2: Experimental Anastrozole + Fulvestrant	Drug: Fulvestrant 250 mg intramuscular injection Drug: Anastrozole 1 mg tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327769

Locations

China
Research Site
He Fei, China
Research Site
Beijing, China
Research Site
Shanghai, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Hankou, China
Research Site
Huangzhou, China
Research Site
Nanjing, China
Research Site
Dalian, China
Research Site
Ji Nan, China
Research Site
Xi AN, China
Research Site
Wuhan, China

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Breast Cancer Established Brands Team Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D6997L00004
Study First Received:	May 18, 2006
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00327769 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by AstraZeneca:

Advanced breast cancer
fulvestrant
anastrozole

Study placed in the following topic categories:

Anastrozole
Estrogens
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Hormone Antagonists
Fulvestrant

Hormones, Hormone Substitutes, and Hormone Antagonists
Breast Neoplasms
Hormones
Estrogen Receptor Modulators
Neoplasm Metastasis
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on May 07, 2009