exemestane in treating postmenopausal women with stage iv breast cancer

Conditions: 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.

primary objectives: i. progression-free survival at 4 months, as measured by response evaluation criteria in solid tumors (recist). secondary objectives: i. objective response rate (complete response \[cr\] and partial response \[pr\]). ii. clinical benefit (cr, pr, and stable disease \>= 6 months). iii. assessment of toxicity. iv. assessment of compliance with medication adherence. v. assessment of quality of life. vi. assessment of bone health. tertiary objectives: i. serial measurements of serum estradiol, estrone, and estrone sulfate. ii. to investigate treatment resistance (e.g., expression of amphiregulin, epidermal growth factor receptor \[egfr\]), using molecular and immunohistochemical analyses of blood and tumor samples of pre- and post- (when available) treatment tissues. microarray analyses to quantitate the expression of specific estrogen-responsive genes (e.g. thyroid transcription factor 1 \[ttf1\] and pdzk1) will also be performed. outline: patients receive exemestane orally (po) once daily (qd) on days 1-14. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. after completion of study therapy, patients are followed periodically for 1 year.

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

Keywords: recurrent breast cancer stage iv breast cancer