Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer
Summary
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.
Description
OBJECTIVES:
Primary
- To measure overall response rate (ORR) in premenopausal women treated with an aromatase inhibitor (AI) and ovarian suppression (OS).
Secondary
- 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.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Breast Cancer
Intervention
goserelin, letrozole, leuprolide acetate, conventional surgery
Location
Seattle Cancer Care Alliance
Seattle
Washington
United States
98109-1023
Status
Terminated
Source
University of Washington
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00498901
- Information obtained from ClinicalTrials.gov on May 12, 2013
Medical and Biotech [MESH] Definitions
Goserelin
A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.
Megestrol
17-Hydroxy-6-methylpregna-3,6-diene-3,20-dione. A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.
Megestrol Acetate
Megestrol acetate is a progestogen with actions and uses similar to those of the progestogens in general. It also has anti-androgenic properties. It is given by mouth in the palliative treatment or as an adjunct to other therapy in endometrial carcinoma and in breast cancer. Megestrol acetate has been approved to treat anorexia and cachexia. (From Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
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