A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00241449

Purpose

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Condition	Intervention	Phase
Breast Cancer Metastasis	Drug: Fulvestrant Drug: Tamoxifen	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate Ici 182780

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Time to disease progression (TTP)

Secondary Outcome Measures:

Objective response rate (ORR), Duration of response (DoR), Time to treatment failure (TTF), Overall survival (OS), Quality of Life (QOL) and Tolerability.

Enrollment:	51
Study Start Date:	November 1998
Estimated Study Completion Date:	March 2012
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Tamoxifen	Drug: Tamoxifen 20 mg oral tablet Other Name: Nolvadex
Experimental: 2 Fulvestrant	Drug: Fulvestrant intramuscular injection 250 mg Other Names: Faslodex ZD9238

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.

Postmenopausal women. Written informed consent to participate in the study.

Exclusion Criteria:

Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.

Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.

Treatment with an investigational or non-approved drug within one month of then start of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241449

Show 139 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Oncology Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00241449 History of Changes
Other Study ID Numbers:	9238IL/0025
Study First Received:	October 17, 2005
Last Updated:	April 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Locally advanced breast cancer or metastatic breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Tamoxifen
Fulvestrant
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on February 09, 2012