Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer - Full Text View

Purpose

The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal women with estrogen receptor positive disease.

Condition	Intervention	Phase
Breast Cancer	Drug: Fulvestrant	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Fulvestrant

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Anti-proliferative effect after 4 weeks of treatment.

Secondary Outcome Measures:

Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.


Enrollment:	179
Study Start Date:	June 2004
Study Completion Date:	July 2007

Arms	Assigned Interventions
Experimental: 1 250 mg fulvestrant	Drug: Fulvestrant 250 mg & 500 mg intramuscular injection Other Names: FASLODEX™ ZD9238
Experimental: 2 500 mg fulvestrant	Drug: Fulvestrant 250 mg & 500 mg intramuscular injection Other Names: FASLODEX™ ZD9238

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women defined as women who have stopped having menstrual periods
Written informed consent to participate in the trial
Biopsy confirmation of invasive breast cancer
Evidence of hormone sensitivity
Willingness to undergo biopsies

Exclusion Criteria:

Any previous treatment for breast cancer
Unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
Any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
The presence of more than one primary tumor
History of hypersensitivity to castor oil
History of known bleeding disorders

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093002

Show 32 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Faslodex Medical Science Director, MD	AstraZeneca

More Information

Additional Information:

Medline Plus - Information on Breast Cancer This link exits the ClinicalTrials.gov site

Breastcancer.org This link exits the ClinicalTrials.gov site

Cancerguide.org - Pros and Cons of Researching Your Cancer This link exits the ClinicalTrials.gov site

Faslodex Information This link exits the ClinicalTrials.gov site


ClinicalTrials.gov Identifier:	NCT00093002 History of Changes
Other Study ID Numbers:	9238IL/0065 D6997C00003
Study First Received:	September 28, 2004
Last Updated:	June 11, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:


Early Breast Cancer neoadjuvant therapy hormonal treatment newly diagnosed breast cancer Estrogen Receptor Positive Breast Cancer	treatment naïve neoadjuvant treatment neoadjuvant setting invasive breast cancer

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estrogens Estradiol Fulvestrant	Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists

ClinicalTrials.gov processed this record on September 23, 2016