Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Treatments: Estrogens; Goserelin; Letrozole; Leuprolide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed carcinoma of the breast

• Metastatic disease

• Measurable disease (i.e., unidimensional by RECIST)

• No rapidly progressing visceral involvement (e.g., liver or lymphangitic lung disease)

• No known marrow involvement as evidenced by diffuse uptake by imaging studies or bone marrow biopsy or aspirate

• No evidence of CNS metastases

• Estrogen- and/or progesterone-receptor positive status confirmed in primary breast tumor or in recent biopsy of metastatic site

PATIENT CHARACTERISTICS:

• Female

• Premenopausal*, as defined by the following criteria:

• Less than 12 months from last menstrual period or premenopausal estradiol within the past 12 months

• No prior bilateral oophorectomy

• 45 years old or younger with intact ovaries and not a candidate for aromatase inhibitor therapy alone due to the potential for recurrent ovarian function NOTE: *Women are considered premenopausal after prior hysterectomy if they have intact ovaries and follicular hormone levels consistent with the institutional normal values for the premenopausal state

• Women meeting premenopausal criteria prior to receiving ovarian suppression are eligible

• ECOG performance status 0-2

• Life expectancy ≥ 3 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective nonhormonal contraception during and for 12 weeks after discontinuation of study therapy

• ANC ≥ 500 cells/mm³

• Platelet count ≥ 50,000 cells/mm³

• Hematocrit ≥ 28%

• In the absence of liver metastases:

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• In the presence of liver metastases:

• AST and ALT ≤ 5 times ULN

• Alkaline phosphatase ≤ 5 times ULN

• In the presence of bone metastases:

• AST and ALT ≤ 10 times ULN

• Alkaline phosphatase ≤ 10 times ULN

• Total bilirubin ≤ 2 times ULN

• No significant comorbid conditions, including any of the following:

• Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias)

• Myocardial infarction within the past 12 months

• Serious concurrent infection

• No lack of physical integrity of the upper gastrointestinal tract

• No inability to swallow or malabsorption syndrome

• No other carcinoma within the past 5 years except nonmelanoma skin cancer and treated in situ cervical cancer

• No mental illness

• No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH-agonist analogues, or any of the components in goserelin

PRIOR CONCURRENT THERAPY:

• No concurrent chemotherapy and/or additional hormonal therapy

• Concurrent trastuzumab (Herceptin®) for patients with HER2 overexpression allowed