Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: exemestane; laboratory biomarker analysis; quality-of-life assessment; immunohistochemistry staining method
Intervention description: Given orally; One year after completion of study treatment; One year after completion of study treatment; Correlative studies
Intervention MeSH terms: Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IV breast cancer

Summary:

      RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
      exemestane may fight breast cancer by lowering the amount of estrogen the body makes.

      PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal
      women with stage IV breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic carcinoma of the breast

          -  Hormone receptor (estrogen receptor [ER] and/or progesterone receptor [PR]) positive
             disease (defined as: ER and/or PR positivity as >= 5% staining), as confirmed by
             immunohistochemistry (IHC) based on primary breast tissue or metastatic tissue

          -  Postmenopausal, as defined by any of the following:

          -  Natural menopause, with at least 1 year since last menses

          -  Chemotherapy-induced menopause with at least 1 year from last menses and serum
             luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and estradiol levels
             within the postmenopausal range

          -  History of surgical or radiation-induced ovarian ablation

          -  For women =< 56 years old and with a history of hysterectomy but at least one ovary
             intact, serum LH/FSH and estradiol levels must be within the postmenopausal range

          -  Postmenopausal women with disease recurrence while receiving either tamoxifen or a
             non-steroidal aromatase inhibitor (AI) as adjuvant therapy (as long as adjuvant
             hormonal therapy was taken for 6 months before disease progression) or with disease
             recurrence following the discontinuation/completion of adjuvant hormonal therapy

          -  Postmenopausal women with disease progression following either 0, 1 or 2 prior
             hormonal therapies for metastatic breast cancer, as long as the subject has had no
             prior exposure to exemestane (EXE)

          -  Measurable or non-measurable (but evaluable) disease, as defined by RECIST criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Neutrophil count >= 1.5 X 10^9 cells/L

          -  Platelet count >= 100 X 10^9 cells/L

          -  Serum creatinine =< 1.5 times upper limit of normal (ULN)

          -  Total serum bilirubin =< 1.5 times ULN

          -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels =< 2.5 x ULN in
             patients without liver metastases or =< 5 times ULN in patients with liver metastases

          -  Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver
             metastases

          -  Subjects must have an estimated life expectancy of greater than 6 months

        Exclusion Criteria:

          -  Prior exposure to EXE, whether in the adjuvant or metastatic setting

          -  Prior history of any other cancer with the exception of non-melanoma skin cancer and
             treated in situ carcinoma of the cervix

          -  Active or symptomatic central nervous system (CNS) metastasis (stable or treated brain
             metastasis allowed but patients must be off decadron, if given for CNS disease)

          -  Hormone-receptor negative or unknown breast cancer

          -  More than two prior chemotherapy regimen for treatment of metastatic disease (any
             prior chemotherapy given in the adjuvant setting is permitted)

          -  Administration of any other anti-cancer therapy within 2 weeks of initiating study
             treatment; use of bisphosphonates, however, are permitted for patients with known bone
             metastases

          -  Treatment with any other concurrent investigational agent or anti-tumor drug
             (chemotherapy, antibody therapy or other biologic agents), will not be permitted

          -  Subjects who have had no prior exposure to endocrine therapy

          -  Any uncontrolled medical co-morbidity or psychiatric disorder which interferes with
             the ability to provide informed consent or comply with study procedures