Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer
RATIONALE: Aromatase inhibitors, such as letrozole, prevent the formation of estradiol, a female hormone. Giving letrozole together with goserelin, leuprolide, or surgery may be an effective treatment in women with hormone-dependent breast cancer.
PURPOSE: This phase II trial is studying how well giving letrozole together with goserelin or leuprolide works in treating premenopausal estrogen receptor-positive patients with stage IV breast cancer.
Drug: leuprolide acetate
Procedure: conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Overall response rate as measured by RECIST [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Time to death [ Designated as safety issue: No ]
- Clinical benefit rate [ Designated as safety issue: No ]
- Qualitative and quantitative toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Comparison of response with results of previous studies of postmenopausal women treated with aromatase inhibitor (AI) therapy and of premenopausal women treated with ovarian suppression (OS) and tamoxifen [ Designated as safety issue: No ]
- Determination of adequacy of estrogen suppression by AI therapy and OS [ Designated as safety issue: No ]
|Study Start Date:||February 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
- 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 and OS.
- 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 OS.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00498901
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Principal Investigator:||Hannah M. Linden, MD||University of Washington|