A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer
- Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29
and then every 28 days thereafter.
- Participants will have a physical examination and blood work performed on each
treatment date. After teh study treatment has been completed, the physical
examinations will be done every three months for the first 2 years, every 6 months for
years 2-5, and annually after 5 years.
- Participants may remain on study treatment until disease progression or until they
experience serious side effects.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant.
Steven Come, MD
Beth Israel Deaconess Medical Center
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Lowell General Hospital||Lowell, Massachusetts 01854|
|South Shore Hospital||South Weymouth, Massachusetts 02190|
|Massachusetts General Hosptial||Boston, Massachusetts 02114|