Phase II Pilot of Aromatase Inhibitor Therapy With Femara® (Letrozole) and Ovarian Suppression in Premenopausal Estrogen Receptor Positive Women With Stage IV Carcinoma of the Breast
- To measure overall response rate (ORR) in premenopausal women treated with an aromatase
inhibitor (AI) and ovarian suppression (OS).
- To measure time to treatment failure (TTF) in premenopausal women treated with an AI
- To measure time to progression (TTP) in premenopausal women treated with an AI and OS.
- To measure time to death in premenopausal women treated with an AI and OS.
- To assess the clinical benefit rate (CBR) in premenopausal women treated with an AI and
- To measure the qualitative and quantitative toxicity of an AI and OS.
- To determine whether ORR, TTP, and CBR are similar to what is seen in postmenopausal
women treated with an AI.
- To determine whether ORR, TTP, and CBR are similar to what is seen in premenopausal
women treated with tamoxifen and OS.
- To determine if levels of estrogen (i.e., estradiol or estrone) are adequately
suppressed in premenopausal women on an AI and OS.
OUTLINE: This is a pilot, open-label study.
Patients undergo surgical ovarian suppression (OS) or medical OS with luteinizing
hormone-releasing hormone (LHRH) agonist (i.e., goserelin or leuprolide acetate,
intramuscularly once monthly for 3 months and then every 2 months thereafter for the
duration of study therapy). Beginning on day 14 after initiation of LHRH-agonist therapy or
surgery, patients receive oral letrozole once daily. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Menopausal status is tested periodically during study by measuring serum estradiol levels.
Patients not converting to a menopausal state after the first month of study therapy,
receive a higher dose of LHRH and undergo repeat estradiol testing in the second month. If
the patient continues to be premenopausal, they are then considered for bilateral
salpingo-oophorectomy or removed from study.
After completion of study therapy, patients are followed every 3 months for 2 years, every 6
months for 2 years, and annually thereafter.
Masking: Open Label, Primary Purpose: Treatment
Overall response rate as measured by RECIST
Hannah M. Linden, MD
University of Washington
United States: Federal Government
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|