Breast Cancer Clinical Trial
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).
| Verified date | June 2008 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 179 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Salzburg | |
| Austria | Research Site | Vienna | |
| Austria | Research Site | Wien | |
| Brazil | Research Site | Barretos | |
| Brazil | Research Site | Florianopolis | |
| Brazil | Research Site | Goiamia | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Rio de Janeiro | |
| Brazil | Research Site | Santo Andre | |
| Brazil | Research Site | Sao Paulo | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | Munchen | |
| Germany | Research Site | Rostock | |
| India | Research Site | Bangalore | |
| India | Research Site | Hyderabaad | |
| India | Research Site | New Delhi | |
| India | Research Site | Pune | |
| India | Research Site | Trivandrum | |
| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | Bournemouth | |
| United Kingdom | Research Site | Dundee | |
| United Kingdom | Research Site | Edinburgh | |
| United States | Research Site | Albuquerque | New Mexico |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Hershey | Pennsylvania |
| United States | Research Site | Laredo | Texas |
| United States | Research Site | Little Rock | Arkansas |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Winchester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Austria, Brazil, Germany, India, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anti-proliferative effect after 4 weeks of treatment. | |||
| Secondary | Safety, tolerability, tumor response and pharmacokinetics after 4 weeks of treatment. |
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