Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
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ClinicalTrials.gov Identifier: NCT00093002 |
Recruitment Status :
Completed
First Posted : September 29, 2004
Last Update Posted : June 12, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: Fulvestrant | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 179 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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). |
Study Start Date : | June 2004 |
Actual Study Completion Date : | July 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
250 mg fulvestrant
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Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
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Experimental: 2
500 mg fulvestrant
|
Drug: Fulvestrant
250 mg & 500 mg intramuscular injection
Other Names:
|
- Anti-proliferative effect after 4 weeks of treatment.
- Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment.

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00093002

Study Director: | AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca |
Additional Information:




ClinicalTrials.gov Identifier: | NCT00093002 History of Changes |
Other Study ID Numbers: |
9238IL/0065 D6997C00003 |
First Posted: | September 29, 2004 Key Record Dates |
Last Update Posted: | June 12, 2008 |
Last Verified: | June 2008 |
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 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Estrogens Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists |