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A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: October 17, 2005   Last Updated: September 30, 2009   History of Changes
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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: December 2010
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Tamoxifen
Drug: Tamoxifen
20 mg oral tablet
2: Experimental
Fulvestrant
Drug: Fulvestrant
intramuscular injection 250 mg

  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

  Hide Study Locations
Locations
United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
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Fountain Valley, California, United States
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La Jolla, California, United States
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Orange, California, United States
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Telford, United Kingdom
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Worthing, United Kingdom
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Belfast, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Oncology Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: 9238IL/0025
Study First Received: October 17, 2005
Last Updated: September 30, 2009
ClinicalTrials.gov Identifier: NCT00241449     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Locally advanced breast cancer or metastatic breast cancer

Additional relevant MeSH terms:
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Fulvestrant
Breast Neoplasms
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
 Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009



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